Articles Posted in Product Liability

A class I product recall has been issued by the FDA for the Puritan Bennett 840 Series Ventilator manufactured by Covidien. A software problem may cause the Ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. This medical device is usually used on critically ill patients who may not be able to breathe without the ventilator. Therefore if the ventilator inadvertently stops the patient may suffer serious personal injury or death.

Read the complete FDA safety Alert

Some companies recently advertised the Nipple Aspirate Test as a method for breast cancer screening. The Nipple AspirateTest consists of using a breast pump to collect fluid from a woman’s nipple to screen for breast cancer. According the the FDA there is absolutely no clinical evidence to support these claims. So far the mammogram, even though it is uncomfortable for women, is the only way to screen for breast cancer.

The company that is promoting this false advertising is Atossa Genetics. Atossa Genetics was issued a warning by the FDA that their test test was misbranded in that its labeling was false or misleading and asking them to address the violation. Atossa Genetics voluntary recalled the ForeCYTE Breast Health Test from the market in October 2013.

In its advertising Atossa Genetics falsely claimed that the test was “literally a Pap smear for breast cancer.”

Toy testing, toy recalls, toy related injuries and toy shopping will be the subject of the first Google+ Hangout hosted by the CSPC. John Massale, A CSPC engineer, will describe the toy testing process and spokeswoman Nikki Fleming will there to answer all your questions.

You can post your questions on Twitter using #AskCPSC hashtag or on CPSC’s G+ Hangout event page.

Some defective Personal Emergency Reporting System (PERS) Transmitters are being recalled by Linear because the battery clips in the transmitters can corrode causing the transmitters to operate intermittently or not at all, without generating a warning.

The recalled Linear PERS transmitters allow users to push a button on the transmitter to summon assistance. Models recalled are:

• The DXS-LRC, a gray plastic pendants with a black circle in the center and can be worn as a pendant around the neck or on a wristband.
• The DXS-LRP, a white pendant with a green swirl design on the front.
• The DXS-LRW a solid black wristband with a black plastic face and black button in the center.

A defective electrical component in Philips HeartStart defibrillators may fail to deliver a needed shock in case of emergency, warned the FDA yesterday. This safety alert by the FDA follows the recall by Philips of three models of its HeartStart devices in September 2012 due to an internal electrical malfunction.

The recall affects about 700,000 defibrillators sold between 2005 and 2012. The FDA recommends Customers who have received the affected devices contact Philips at 1-800-263-3342 to receive a replacement.

A defective air pressure switch in some Crown Home Heating Boilers can fail to shut down the burners allowing the boiler to emit excessive amounts of carbon monoxide, exposing consumers to CO poisoning hazard. Carbon monoxide poisoning is extremely dangerous because it is a deadly odorless gas. Carbon monoxide poisoning is the leading cause of poisoning death in the United States.

The models involved in the recall are Crown Boiler CWD series cast iron hot water boilers that use natural gas or liquid petroleum to heat water in home baseboard, floor or radiator heating systems. The boilers are red and gray, about 37 inches tall, about 23 inches deep and range from about 16 to 42 inches wide. The Crown Boiler logo is on the front of the boiler. Recalled boilers have model numbers that begin with CWD and were manufactured between May 1, 2005 and July 1, 2013.

For complete information on model numbers and repair go to the CPSC website

To prevent dangerous and defective products from reaching American consumers, the CPSC has been using a state-of-the-art risk assessment tool pilot called risk assessment methodology (RAM) for its port surveillance. As a result, the screenings led to the identification of about 680 shipments containing violative or defective products, totaling about 6.1 million units for the first half of the 2013 fiscal year. About 600 of the product shipments stopped were children’s products totaling about 1.2 million units. This compares to approximately 450 product shipments stopped with a total of 900,000 units during the same period in the 2012 fiscal year.

Read more on the CSPSC website

All GemStar Infusion Pumps that were either manufactured or had a pressure sensor replaced during servicing of the pump since January 1, 2009 are being subjected to a FDA Class I recall because of a potential pressure sensor calibration drift.

A calibration drift is a gradual degradation of the sensor and other components that can make readings offset from the original calibrated state. A pump with this issue may, instead of reporting an error, not detect occlusions or issue false occlusion alarms, which will stop the infusion and invoke visual and audible warnings to the user. This issue may also result in the pump shutting down.

As a consequence the patient therapy may be delayed or interrupted which may result in significant injury or death.

Some potentially defective Anesthesia workstations and service kits manufactured by Spacelabs Helathcare are subject to a class I recall by the FDA. The recalled models are the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation, and Service Kits Part Number 050-0659-00 and 050-0901-00.

These products are used in hospitals. They provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.

The defective products may cause serious adverse health consequences, including death.