BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT BATTERY

    MDR report key: 644980 · Received November 1, 2005

    Report

    Report Number
    644980
    Event Type
    Malfunction
    Date Received
    November 1, 2005
    Date of Event
    October 28, 2005
    Report Date
    November 1, 2005
    Manufacturer
    DIVERSIFIED MEDICAL NCE
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US

    Narratives

    Description of Event or Problem · 1

    TWO REPLACEMENT BATTERIES FOR A PHYSIO-CONTROL LP8 DEFIBRILLATOR WERE ORDERED FROM DIVERSIFIED MEDICAL. WHEN THE TECHNICIAN INSTALLED THE BATTERIES THE DEFIBRILLATOR SPARKED AND SMOKED. IT WAS DISCOVERED AFTER THE BATTERIES WERE INSTALLED IN ANOTHER DEFIBRILLATOR THAT DID THE SAME THING, THAT THE POLARITY OF THE REPLACEMENT BATTERIES WAS REVERSED. THE TECHNICIAN CONTACTED DIVERSIFIED MEDICAL AND ADVISED THEM OF THE PROBLEM WITH THE BATTERIES AND THEY OFFERED TO PAY FOR THE REPAIR OF THE DEFIBRILLATORS. THE BATTERIES ARE PACKAGED AS A SET OF TWO AND HAVE THE SAME PART AND LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT BATTERY BATTERY LDD DIVERSIFIED MEDICAL NCE PHYSIO LP8 BATPAK L4344

    Patients

    Seq Age Sex Outcome Treatment
    1 *