BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1710063 · Received May 28, 2010

    Report

    Report Number
    3015876-2010-00690
    Event Type
    Malfunction
    Date Received
    May 28, 2010
    Date of Event
    April 30, 2010
    Report Date
    April 30, 2010
    Manufacturer
    PHYSIO-CONTROL
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON BATTERY POWER. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED POWER SUPPLY ASSEMBLY AND OBSERVED EXCESSIVE ELECTRICAL LEAKAGE FROM TWO FILTERS, DESIGNATOR FL4 AND FL10, DUE TO SOLDER FLUX RESIDUE ON THE POWER PCB SURFACE. THE OBSERVED FAILURE IS KNOWN TO CAUSE A NO BATTERY OPERATION FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON BATTERY SOURCE. THERE WAS NO REPORT OF PT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 20 DEFIBRILLATOR/MONITOR LDD PHYSIO-CONTROL 20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA