FDA Adverse Event Injury Summary report: N

LAERDAL HEARTSTART FR2

MDR report key: 975303 · Received January 2, 2008

Report

Report Number
MW5004869
Event Type
Injury
Date Received
January 2, 2008
Date of Event
January 2, 2008
Report Date
January 2, 2008
Manufacturer
AGILENT TECHNOLOGIES
Product Code
MKJ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NJ, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

POLICE DEPT HAS SIXTEEN LATERDAL/PHILIPS MEDICAL FR2 AED'S IN SERVICE. OVER THE LAST THREE YEARS, EIGHT OF THE UNITS HAVE SUFFERED FAILURE OF THE AUDIBLE SPEAKER. THE LACK OF AN AUDIBLE SPEAKER MAKES THE RESUSCITATION PROCESS MUCH MORE DIFFICULT BECAUSE THE OFFICER MUST WATCH THE SCREEN FOR INSTRUCTIONS WHILE PERFORMING CPR AND USING THE UNIT. IT IS ALSO VERY DIFFICULT TO READ THE SCREEN IN A SUNNY ENVIRONMENT. AS A RESULT, THE DEPARTMENT HAS HAD TO REPLACE THE FAILED UNITS . PHILIPS MEDICAL DOES NOT REPAIR THE DEVICES AND ACKNOWLEDGES NO PRIOR HISTORY OF SPEAKER FAILURE PROBLEMS. ONCE THE WARRANTY PERIOD EXPIRES, THEY ONLY OFFER THE OPTION OF THE PURCHASE OF A NEW UNIT. THE DEPARTMENT HAS ACQUIRED REFURBISHED UNITS IN EXCHANGE FOR FAILED UNITS WHICH WERE UNDER WARRANTY, HOWEVER THOSE UNITS HAVE SUFFERED SPEAKER FAILURE AS WELL. I FOUND AN ADVERSE EVENT REPORT FROM MFR-PRODUCER OF FR2- FROM 2002 DOCUMENTING AN INCIDENT OF SPEAKER FAILURE. IT INDICATED THAT THE FAILURE WAS THE RESULT OF A FRACTURED SPEAKER WIRE. I FEEL THAT IT IS RIDICULOUS FOR A GOVERNMENT AGENCY -OR ANY AGENCY- TO HAVE TO SPEND BECAUSE OF A BROKEN SPEAKER WIRE. I BELIEVE THAT PHILIPS MEDICAL SHOULD RECALL THE FR2 UNITS AND ADDRESS THE SPEAK WIRE ISSUE. THANK YOU FOR YOUR CONSIDERATION IN THIS MATTER.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 LAERDAL HEARTSTART FR2 LAERDAL HEARTSTART FR2 MKJ AGILENT TECHNOLOGIES M3841

Patients

Seq Age Sex Outcome Treatment
1 YR Life Threatening