BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEWLETT PACKARD

    MDR report key: 491696 · Received October 17, 2003

    Report

    Report Number
    491696
    Event Type
    Death
    Date Received
    October 17, 2003
    Date of Event
    June 1, 2003
    Report Date
    July 1, 2003
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USING DEFIB PADDLES DURING A CODE THERE WAS A SLIGHT SMELL OF BURNING FLESH AFTER THE FIRST SHOCK. NO BURN WAS NOTED. THE MONITOR SCREEN WHEN IN ANY LEAD DID NOT HAVE GOOD CAPTURE. THE GAIN WAS INCREASED AND THE RHYTHM WAS NOW LARGE, BUT THERE WAS STILL A LOT OF ARTIFACT PRESENT. THE LEADS AND PADS WERE CHANGED, AND ALL CONNECTIONS CHECKED. THE MONITOR WAS NOT SHOWING A GOOD STRIP AND WOULD GO IN AND OUT WHEN THE LEADS WERE CHANGED. THERE COULD BE PROBLEMS WITH THE LEADS AND PADDLES; THE REPORTING RN FELT THE ENTIRE MACHINE WAS BAD. THE MACHINE IS 12-15 YEARS OLD AND THE MFR WON'T WORK ON IT ANYMORE. IT WILL NOT BE SENT TO THE MFR. MAINTENANCE DEPT WORKED ON IT AND IT IS NOW AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEWLETT PACKARD DEFIBRILLATOR LDD PHILIPS MEDICAL SYSTEMS, INC. 43110A STD

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death