BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    MDR report key: 1082120 · Received July 25, 2008

    Report

    Report Number
    3015876-2008-00833
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    February 11, 2008
    Report Date
    June 27, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    PMA / PMN Number
    K012274
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE, AND OBSERVED THAT IT WOULD NOT OPERATE ON AC POWER. THE SERVICE REP 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 REPLACED POWER SUPPLY ASSEMBLY AND DETERMINED THAT ROOT CAUSE FOR THE REPORTED INCIDENT WAS AN ELECTRICAL SHORT THROUGH FET TRANSISTOR, DESIGNATOR Q6, AND DIODE, DESIGNATOR D1. FUSE F1 WAS ALSO FOUND OPEN.

    Description of Event or Problem · 1

    THE CUSTOMER REQUESTED A REPLACEMENT DEVICE DUE TO THE NUMBER OF REPAIRS THE DEVICE HAS REQUIRED SINCE THEY FIRST PURCHASED IT 3 YEARS AGO. WHEN THE RETURNED DEVICE WAS EVALUATED BY PHYSIO-CONTROL, A FAILURE TO OPERATE ON AC POWER WAS FOUND.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA