Exclusives
FacebookTwitterLinkedInGoogle+RSS Feed
Fire EMSEMS TodayEMS Insider

Defibrillators Recalled After Reported Incidents

WASHINGTON - Welch Allyn is recalling about 14,000 external defibrillators after 39 reported incidents, including two that involved patient deaths.

The recall, announced Tuesday, involves 14,054 AED 10 and MRL JumpStart external defibrillators made between Oct. 3, 2002, and Jan. 25, 2007. The Beaverton, Ore., company says there is a remote chance the devices, available through prescription, may produce low-energy shock, shutdown unexpectedly or be susceptible to electromagnetic noise interference.

The issues might prevent defibrillation of a patient in cardiac arrest and could lead to death, the company said in a statement. The company had received 20 instances of low-energy shock, eight instances of electromagnetic noise interference, and 11 instances of the device unexpectedly shutting down.

To the company's knowledge, the defects of the device did not contribute to the two deaths, said spokesman Jamie Arnold. "Human factors played a role in each incident: damaged device in one and failure to follow directions in the other," he said in an e-mail.

The company said customers should keep AED 10 or MRL JumpStart units in use until they receive replacements because the chance of malfunction is low.

In October 2007, the company announced another recall of 1,794 AED10 automatic external defibrillators. The devices could fail or produce a delay in analyzing a patient's ECG and may not deliver appropriate therapy. This could result in failure to resuscitate the patient. No injuries associated with this product had been reported, but the company had reported 49 failures during internal testing and had received three customer complaints.

For more information, consumers can contact the company at 888-345-5356 or visit http://www.welchallyn.com/AED10Recall.

Any reactions should be reported to the Food and Drug Administration's MedWatch adverse event reporting program at http://www.fda.gov/medwatch/report.htm.

RELATED ARTICLES

Cardiac Arrest Registry to Enhance Survival to Begin Collecting Data to Measure CPR Quality

Data will assist in providing uniform reporting metrics back to agencies to assist with their internal quality improvement efforts.

Epileptic Effect: The Aftermath of a Seizure isn’t Always What it Seems

You and your partner are dispatched to a 60ish-year-old female with signs and symptoms of a possible stroke.

Thorough Assessment is Crucial in Patients with Respiratory Distress

Accurate observation and treatment go a long way when considering all causes of respiratory distress.

Oklahoma City & Tulsa EMS Become First System to Adopt ResQCPR as a Standard of Care

Today the Medical Control Board for the EMS System for Metropolitan Oklahoma City and Tulsa, Okla., unanimously voted to approve the ResQCPR system by ZOLL a...

Tilt Angle Significantly Affects CPR

Test on pigs show patient tilt angle can have a positive effect on cerebral perfusion.

ZOLL ResQCPR™ System Receives Premarket Approval from the FDA

Chelmsford, Mass.— ZOLL® Medical Corporation, a manufacturer of medical devices and related software solutions, today announced that the company&rs...

Features by Topic

JEMS TV

FEATURED VIDEO TOPICS

Learn about new products and innovations featured at EMS Today 2015

 

JEMS Connect

CURRENT DISCUSSIONS

 
 

EMS BLOGS

Blogger Browser

Today's Featured Posts

Featured Careers