2012 Archives - 31/214 - Archive

A medical device company is making it known that one of their products needs to be corrected in order to be able to ensure that the item works properly.

The item requiring the correction is the Samaritan 300/300P PAD public access defibrillator, and the announcement was made by HeartSine Technologies.  Affected units were produced between August 2004 and December 2010.  Each one has a warranty of seven years.

There are two potential issues that could hinder the proper usage of these defibrillators in the event that somebody suffers some type of cardiac event and needs immediate assistance.  First, there exists a software issue plaguing early models of the items wherein the system inaccurately detects a temporary battery voltage drop as a low battery situation.  As a result, the machine might get turned off.  The other issue stems from the possibility that the defibrillator could potentially turn off and on without prompting.  This could lead the batter to lose power over time.

The danger from the latter issue is reportedly mitigated if the owner has an appropriate power source that offsets the depleted battery.  However, the company will still be giving out PAD-PAKs to affected customers along with instructions detailing how to use the pak during a rescue.  That way, assistance will always be possible.

A software upgrade should be able to take care of the other issue.  The on/off risk has not led to any reported injuries or fatalities, but five fatality reports have been received by HeartSine in which the company has yet to rule out the software error as being related to the incident.

A dietary supplement company that allegedly failed to meet requirements set forth by the Food and Drug Administration will halt production until such time that safety can be ensured.

The company being targeted by the safety organization is the Hauppage, New York-based Venus Pharmaceuticals International.  Not long ago, the FDA conducted inspections of their facility in a bid to make sure the company was adhering to current good manufacturing practices, otherwise known as cGMP.  They discovered that the company was lacking in controls that could guarantee product specifications were being met.

Venus pledged to correct the issue, but when the FDA conducted a follow-up investigation, they ascertained that whatever corrections may have been taken did not bring the company into compliance with requirements.  The breach in these requirements meant that any items from Venus would be considered adulterated as expressed in the Federal Food, Drug, and Cosmetic Act.

Now, Venus has come to an agreement with the FDA wherein they will cease making and distributing their supplements until they can fix their safety issues.  They must alter a variety of procedures in order to come into compliance with guidelines.  An auditor will be brought in to ensure this compliance over the next two years.  Plus, the FDA now has the right to initiate an inspection whenever they see fit.

No one has reported becoming ill from a Venus dietary supplement at this time.

The Food and Drug Administration is attempting to warn parents about the danger presented to unwitting children by nasal sprays and over the counter eye drops.

These products can easily be swallowed by children if they are left out where a kid could easily get ahold of them.  The threat comes in the form of the drugs typically contained within such items.  Products like Mucinex, Visine, and more contain such things as naphazoline, oxymetazoline, and tetrahydrozoline, and if a child swallows just one teaspoon of a drop or spray, he or she could experience an adverse health event.

In fact, between 1985 and this year, there have been a confirmed 96 instances where a kid up to the age of five accidentally swallowed an item containing one of the aforementioned drugs.  Thankfully, none of those situations reportedly led to a fatality, but 53 of the incidents required hospitalization to treat things like vomiting, a rapid heart beat, and even comas.

The Consumer Product Safety Commission has been in the process of trying to pass a rule that would require such items to be contained within a child-proof package, but there have not been any concrete results yet.  That’s why the FDA is asking parents to keep the items away from kids at all times.  If the child still gets ahold of the medicine, a doctor should be sought and the Poison Control Center should be called.

An item meant to be used by cyclists is being recalled due to the danger it could pose to those same persons.

Bike wheel rim tape with the number 700X18 A/V is the subject of the recall, which was announced by the Las Vegas, Nevada-based FLO Cycling LLC.  This yellow tape was actually given away to FLO Cycling customers who bought FLO DISC, FLO 60, and FLO 90 bike wheels.  Numerous serial numbers of wheels are included within the recall, equating to an estimated 800 units of tape that might be affected by a defect.

That defect concerns a potential failure and subsequent breakage of the rim tape should it be placed under pressure.  If this were to occur, it could lead to a burst or a puncture affecting the the bike’s inner tube.  Anyone who happens to be riding the bike when this happens would be in danger of falling.  Four instances of the inner tube exploding and the user thus experiencing a flat tire have taken place at this point, but the good news is that none of those incidents reportedly led to an injury.

This tape was only available from the FLO Cycling website when customers bought the aforementioned wheels.  The wheels that enable a user to get the free tape ran from $375 to $700, and the tape was given away with all those wheels that were sold between May and July of this year.  $5 will be given to those consumers who have received the item.

Santa Clara University has seen a spat of bicycle thefts as of late, and therefore the Cycling Club and Campus Safety are partnering to hold a Bike Safety Fair in a couple weeks.  Locks will be sold to interested students, and officials will also be on hand to fix such bike issues as low tire pressure and handlebar configuration problems.  Students are also being asked to look out for potential thefts and report them as soon as possible to Campus Safety.

Click here for more about this effort.

A wide variety of small animal and bird food products under the Sleek and Sassy brand have been recalled by the Monroe, Oregon-based Wildwood Seed & Specialties.  These items could have suffered a Salmonella contamination due to the presence of peanut products that were supplied by Sunland.  Not only are pets in danger, but humans who come into contact with the pet food could also be at risk.  The products were sold in Washington and Oregon.  They should not be given to pets, and a refund will be issued to those who bring the food back.

Click here for more about the recall.

The Kansas State Police Department wants cyclists and pedestrians alike to understand the rules of the road when it comes to getting across campus.  The captain of the department stated that pedestrians are required by law to utilize the flashing light in the crosswalk to cross the street, while cyclists should get off their bikes if using a crosswalk.  He also expressed his desire to see pedestrians be just as courteous to vehicles as drivers should be to people on foot.

Click here for more about this awareness effort.

Fiscal year 2012 has come to a close as of the end of September, and OSHA is one of those organizations that has collected statistics for the year which started back in October.  And recently, the National Safety Council Congress and Expo was held in Orland, Florida.  OSHA took the time to enlighten the estimated 15,000 attendees as to the most common reported violations that occurred on the job.  This top ten list is essential reading for employers and employees looking to foster a culture of safety at their particular facility.

Leading the list by a wide margin was a violation of fall protection standards meant to prevent injury.  A whopping 7,250 violations were reported, ensuring that this category outdistances the next most common violation by more than 2,500 instances.  Typically, a fall protection violation came in the form of not placing some sort of component in place to limit the potential to fall off an edge of a structure or an open aperture.  Roof fall prevention was also a problem, as was an inability to cover open holes.

The next most typical violation, clocking in at under 5,000, was a lack of some sort of communication system that would inform employees of the potential dangers they might encounter on a given job.  That means that the employer might fail to provide a safety program in writing, they may have not trained or educated an employee properly, or they didn’t place the necessary labels or signage on various containers.

Scaffolding issues were up next, which sometimes goes hand in hand with fall protection.  In many instances, there weren’t the necessary guardrails in place on these items, but there were also issues where the scaffold itself wasn’t built properly or it was difficult for employees to get to them in a safe manner.

Problems that might lead to an employee incurring some type of respiratory injury were up next.  That might mean that there wasn’t a breathing protection program in writing, fit test procedures were not well-made, or procedures were not in place for employees who opted to use a voluntary respirator.

Rounding out the top five were violations related to ladders used during construction.  Oftentimes, a violation in this category would involve someone mistakenly stepping onto the top step, placing too much weight on the ladder, or simply not using the correct ladder for the job that is being carried out.

The rest of the top ten list was filled with such violations as machine guarding issues, powered industrial truck deficiencies, defects in electrical wiring usage, tagging and locking out, and general electrical safety issues.

We’ve started to become used to automotive technology that alerts us to certain hazardous driving situations.  When you leave your lane, your car tells you.  When you’re driving too close to the vehicle ahead of you, your car tells you.  And pretty soon, autonomous vehicle technology will ensure that the car doesn’t just tell you but actually takes control itself.

However, one slightly overlooked aspect of the latest car safety technology is the potential for a vehicle to actually aid a driver’s health.  That’s why Ford is putting energy into the creation of apps that can be used to help keep people with asthma, diabetes, allergies, and more stay safe behind the wheel.

Researchers envision a world where the system can connect with servers in order to access your patient information.  From there, it might be able to do such things as advise you on how to stay healthy while driving, such as offering advice on how to avoid a diabetic episode.  It could do so by way of monitoring your sugar levels and pointing you to a nearby convenience store so you can buy the necessary corrective items should it become necessary to do so.

The technology could also urge you to take a route that is beneficial to your health, allowing you to circumvent neighborhoods where air quality is poor.  Toyota is even in the process of creating a system that would be able to identify a heart attack and react accordingly.

Follow this link to learn more about this exciting technology.

Hunters’ tree stands are being recalled due to the threat they could pose to consumer safety.

14,000 stands in total are thought to be affected by the recall that was announced by the Cumberland, Wisconsin-based Rivers Edge Tree Stands.  Big Foot, Baby Big Foot, and Lite Foot models without an X or an orange dot on their snaphook but that contain 2012 on their ID tag below the crossbar are affected by the recall.

The recall was initiated because it was discovered that a failure can occur in the snap-hook assembly of these items.  If this happens while the hunter is in the stand at the time of the incident, he or she can fall along with the stand.  Three incidents have already been reported to the company.  One person reportedly suffered bumps and bruises while another apparently cut their hand and broke their toe.

Scheels, Rogers Sporting Goods, and a variety of other retailers were responsible for selling these items, which were available across the country between the beginning of May and the end of August.  They ran consumers anywhere from $39 to $120 depending on the model purchased.

Owners of the stands are being asked to not use them until such time that they can obtain a snap-hook assembly replacement component.  This can be obtained by getting in touch with Rivers Edge, who will make the replacement available at no cost to the consumer.