Welch Allyn Defibrillator Recall
Defective Welch Allyn AEDs can experience unexpected shutdown and low defibrillation energy, among other defects. These malfunctions render the device unusable and could result in death. On December 15, 2008 the Welch Allyn AED 10 Automatic External Defibrillator (AED) and the MRL JumpStart AED were the subjects of a Class 1 recall due to chances of low defibrillation energy delivery, unexpected device shutdown and inadequate filtering of electromagnetic noise. Such conditions can prevent defibrillation of a person in cardiac arrest and can lead to death.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
About Malfunctioning Welch Allyn AEDs
These devices are used to treat adults suffering from cardiac arrest. Emergency or medical workers use the device to evaluate heart rhythms and electrically shock the heart in case of abnormal rhythms. The malfunctioning AEDs were manufactured from October 3, 2002 to January 25, 2007. A total of 14,054 defibrillators were recalled after 20 incidents of low defibrillation energy delivery, 8 incidents of inadequate filtering of electromagnetic noise and 11 incidents of unexpected device shutdown. According to Welch Allyn, notification of the recall was sent to U.S. and Canada customers February 2009 and other international customers were to receive notification later in March.
Low Defibrillation Energy Delivery
Both the Welch Allyn AED 10 and the MRL JumpStart defibrillator may have weak solder joints that attach transformers to their circuit board. This could result in the machine delivering between 25 and 100 percent less defibrillating shock than the programmed energy. One death has been reported as a result of Welch Allyn’s AEDs providing low energy shock. This defect was discovered in 17 other devices during routine maintenance. There are 14,012 devices that may have this defect. They were all manufactured between October 2002 and July 2005.
Unexpected Device Shutdown
The AED 10 could unexpectedly shut down during use if the pads are attached to the patient before the device is turned on and the device is set to deliver an initial shock of 150 Joules energy. The user’s instructions on the back of the device and the Quick Reference guide advise against attaching the pads before turning on the device, however, some pages in the user’s manual include illustrations of the pads attached prior to turning on the device.
Welch Allyn advises that you disregard the erroneous illustrations and plans to distribute corrected manuals. WARNING: Units sold outside the U.S. that have the British voice option have a default setting of 150 Joules initial shock. U.S. units have a factory default setting of 200 Joules. The combination of these conditions and ultimate shutdown of the device has resulted in one death. There are 10,735 devices that may have this defect. They were all manufactured between October 3, 2002 and December 30, 2004.
Inadequate Filtering of Electromagnetic Noise
The Welch Allyn AED 10 and MRL JumpStart could have electromagnetic noise interference, causing a shock to be delivered to a patient with a non-shockable rhythm. Simply, in the case of inadequate electromagnetic noise filtering, the device cannot decipher shockable rhythms and, therefore, misfires and fails to fire. There has been one incident in which this occurred and 7 incidents in which the device failed to recognize a shockable rhythm during routine testing. There are 10,735 devices that may have this defect. They were all manufactured between October 3, 2002 and December 30, 2004.
The AED 10 could fail due to blown F1 fuses. In such a case, the device would be inoperable and warning light would illuminate, alerting of the condition. A fuse could blow during use, which would cease defibrillation and possibly result in death. There are 4,568 devices that may have this defect. They were all manufactured between May 18, 2004 and December 30, 2004.
Shutdown in Cold Temperatures
If your device was upgraded with software version 02.06.00, there is a possibility it could shut down during use in cold temperatures. This would render the device inoperable and could result in death. There are 87 devices that may have this defect. They were all serviced in 2007.
Voice Prompt Failure
The AED 10 and MRL JumpStart could fail to deliver voice prompts due to discontinuous speaker connection. There have been 10 such incidents reported. There are 5,336 devices that may have this defect. They were all manufactured between October 3, 2002 and July 26, 2004.
FAQs Regarding the Welch Allyn Recall
- What exactly is affected by the recall? The Welch Allyn AED 10 Automatic External Defibrillator (AED) and the Welch Allyn MRL JumpStart Automatic External Defibrillator (AED).
- What is wrong with the devices? They may contain defects including low defibrillation energy delivery (low energy shock), unexpected device shutdown, inadequate filtering of electromagnetic noise (electromagnetic noise interference), shutdown in cold temperatures, voice prompt failure, and blown fuses.
- How serious is the recall? The recall is a Class 1 recall, which is the most serious type of recall. In such a recall, there is a reasonable probability that use of the product will cause serious injury or death.
- What should I do if I have a Welch Allyn AED 10 or MRL JumpStart AED? You are advised to contact Welch Allyn at 1-888-345-5356 between 8 am and 5 pm Eastern Standard Time and notify them. You can also contact the FDA by mail, fax or online. Mail: MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787; Fax: 1-800-FDA-0178; Online: www.fda.gov/medwatch/report.htm.
- When did FDA issue the recall? The FDA initiated the recall December 15, 2008. Welch Allyn announced their voluntary worldwide recall March 11, 2009.
- What will the FDA do now? The FDA will continue to monitor and oversee the recall in order to protect consumers. Any updates on the recall or the recalled devices will be posted on the FDA’s website.
- Is this recall related to previous recalls? Both the August and October 2007 recalls were related to defective capacitors, which resulted in a delay in analyzing the patient’s ECG and could result in failure to resuscitate a patient. While the current recall is based on 6 other defects, the abundance of defects and the company’s past recalls call for warning and serious precaution.
Injured by a Defective Welch Allyn Device?
If you or a loved one has been injured due to the malfunction of a Welch Allyn AED 10 or MRL JumpStart AED, you may be entitled to compensation for your injuries. At Arnold & Itkin LLP, we have helped many clients recover in the wake of an injury caused by a medical device malfunction. We have the expertise and experience necessary to take on medical device manufacturers like Welch Allyn and get you the compensation you deserve.