Class I Recall Issued for Welch Allyn DefibrillatorsSep 18, 2007 | Parker Waichman LLP, LLP
Welch Allyn Protocol, Inc. has announced a recall of its MRL/Welch Allyn AED 20 Automatic External Defibrillators. The devices are used by emergency and medical personnel to treat adult and pediatric patients suffering a heart attack. The Food & Drug Administration (FDA) has deemed the recall of Welch Allyn’s AED 20 Automatic Defibrillators to be a class I recall.
Welch Allyn initiated the recall of the defective devices on August 24. The company said that the defibrillators may display a “Defib Comm” error message. This will result 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.
Class I recalls are the most serious FDA recalls. 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. Emergency and medical personnel should stop using the AED 20 Automatic External Defibrillators immediately.
The defibrillators involved in this recall are MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2006. They bear serial numbers between 205787 and 207509. Welch Allyn sent a letter to customers who purchased the recalled defibrillators on August 29, 2007. Owners of the AED Automatic External Defibrillators should contact their local Welch Allyn representative to obtain a loaner defibrillator free of charge. Welch Allyn will upgrade the defibrillator at no cost, and will also pay for the shipping and handling of the devices.
This is not the first occasion that Welch Allyn has reported problems with this defibrillator model. Last June, 580 of the devices 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 last year’s defibrillator recall a class I recall.
Customers with questions about this latest recall can contact Welch Allyn at 1-800-462-0777.