By EMS1.com Staff
WASHINGTON — Welch Allyn Protocol, Inc. has issued a mass recall of its MRL/Welch Allyn AED 20 Automatic External Defibrillators, due to a defect that could result in the device’s failure to correctly read heart rhythm.
On Aug. 24, the Food & Drug Administration announced a Class I recall, considered as their highest priority level, on the device due to a “reasonable probability” that its use can result in serious injuries or death.
According to the FDA Web site, “These recalled devices may display a “Defib Comm” error message on the device display during use which may result in a terminal failure of the device to analyze the patient’s ECG and deliver the appropriate therapy.”
Welch Allyn sent a recall letter on Aug. 29 to its customers who purchased the product. AED 20 owners should contact their local Welch Allyn representative to obtain a working AED replacement at no cost until their other unit is fixed, said a response from the company.
Welch Allyn said it will handle all costs associated with the upgrade, as well as shipping and handling.
The FDA has targeted a batch of defibrillators manufactured between Oct. 2003 and Jan. 2005 with serial numbers 205787 through 207509.
According to reports, this is the second time in the last year that Welch Allyn reported malfunctions in their defibrillator model. In June 2006, the FDA issued a similar Class I recall on the device due to a faulty electrical connection that could cause delay or failure in resuscitating the patient.
Customers may contact Welch Allyn by calling 1-800-462-0777. Visit the FDA recall Web site at www.fda.gov/MedWatch/report.htm for the full report.