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Welch Allyn AED 10 Automatic External Defibrillator Recall is Company's Third in 18 Months

Nov 7, 2007 | Parker Waichman LLP

Welch Allyn AED 10 Automatic External Defibrillators are being recalled due to defective capacitors that could cause the devices to fail.  The Welch Allyn AED 10 Automatic External Defibrillator recall includes nearly 1800 defective devices, and is the third defibrillator recall issued by Welch Allyn in the past 18 months.  Welch Allyn AED 10 Automatic External Defibrillators are used by emergency, medical personnel, or other trained individuals to treat adults suffering a heart attack. They analyze an unconscious patient’s heart rhythm and automatically deliver an electrical shock to the heart if needed to restore normal heart rhythm.

The Food & Drug Administration (FDA) has deemed the Welch Allyn AED 10 Automatic External Defibrillator recall a class I recall.  A class I recall is the most serious type of  FDA recall. The FDA issues class I recalls when there is a good chance that the use of a medical device could cause serious injury or death. Because of this risk, emergency and medical personnel should stop using the AED 10 Automatic External Defibrillators immediately.

The Welch Allyn AED 10 Automatic External Defibrillator recall applies to devices manufactured between March 29, 2007 and August 9, 2007 with part numbers 970302E, 970308E, 970310E, and 970311E.   According to a Welch Allyn press release, the defective AED 10 Automatic Defibrillators have malfunctioned on 49 occasions.  The malfunctions have included a flashing status indicator, excessive battery drain resulting in shortened battery life, continuous device resets rendering the device non-operational, and no shock advised with a ventricular fibrillation input. These defects may cause failure or unacceptable delay in analyzing the patient's ECG and may not deliver appropriate therapy, which could possibly result in failure to resuscitate the patient.  According to Welch Allyn, the malfunctions are caused by defective capacitors manufactured by an outside vendor that were used on two lots of printed circuit board assemblies.

This is the third Welch Allyn external defibrillator recall in a year and a half.  In August, Welch Allyn announced a recall of its MRL/Welch Allyn AED 20 Automatic External Defibrillators. At the time, Welch Allyn said that those defective defibrillators might display a “Defib Comm” error message. This resulted in a terminal failure of the defibrillator to analyze an unconscious patient’s heart rhythm and deliver the appropriate electrical shock to restore the normal rhythm.

An earlier recall of that same device was also initiated in June 2006.  At that time, 580 MRL/Welch Allyn AED 20 Automatic External Defibrillators where recalled because the internal electrical connection had a potential to fail. When this happened, it resulted in a delay of ECG analysis and delivery of appropriate resuscitative therapy. According to a news release published by Welch Allyn at the time, 30 cases of that malfunction had been reported, and patient resuscitation was delayed during one of those malfunctions. The FDA also designated both MRL/Welch Allyn AED 20 actions class I recalls.

Customers with questions regarding the Welch Allyn AED 10 Automatic External Defibrillator recall can contact Welch Allyn Technical Support at 1-800-462-0777.


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