Automatic External Defibrillator Recall: Welch Allyn AED 10 and MRL JumpStart AED

Over 14,000 automatic external defibrillators (AED) have been recalled by Welch Allyn, as the devices could malfunction and fail to work when needed to deliver a life-saving charge to someone who is suffering a cardiac arrest.

The external defibrillator recall applies to Welch Allyn AED 10 and MRL JumpStart AED that were manufactured between October 2002 and January 2007. The devices could experience low energy delivery during defibrillation, unexpectedly shutdown or inadequately filter electromagnetic noise.

Automatic external defibrillators (AED) are medical devices that are used to treat adults who have suffered a heart attack, by analyzing the heartbeats of an unconscious person and automatically delivering an electric shock to the heart if needed to restore a normal cardiac rhythm.

The AED 10 and MRL JumpStart AED are used by medical and emergency personnel or by those who have completed training courses in CPR AED.

A number of problem have been reported with the Welch Allyn defibrillators, including at least 40 reports of low energy shock, 11 reports of the devices unexpectedly shutting down and 8 reports of electromagnetic noise interference.

The recall has been classified as a Class 1 recall, which is the most serious type, used in situations hwere there is a reasonable probability that use of the product will cause serious injury or death.

However, Welch Allyn has advised customers that the chance of malfunction is remote, and the automatic external defibrillators are being kept in use until replacement parts are received. If a low energy shock warning occurs, users have been advised to follow the voice prompts and directions.  A low energy shock can be effective, and a full energy shock may follow.

A recall notification letter was sent by the company to distributors and customers on February 26-27, 2009. Additional information can be found at their website, http://www.welchallyn.com/AED10Recall.

Customers in the U.S. and Canada may exchange their Welch Allyn AED 10 or buy a new AED 10 directly from Welch Allyn at a reduced cost. International customers will be offered an exchange. The FDA has been notified of the company’s action.