BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1051170 · Received May 22, 2008

    Report

    Report Number
    3015876-2008-00527
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    November 27, 2007
    Report Date
    April 22, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K973486
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE, AND OBSERVED THAT THE DEVICE WOULD NOT POWER ON. THE SYSTEM AND THE AUXILIARY CONNECTORS WERE BROKEN AND COULD NOT CONNECT ANY CABLES TO THEM. PHYSIO REPLACED THE CONNECTORS, RE-CONNECTED WIRE ASSEMBLIES, REPLACED THE CASE, AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND DEVICE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE ROOT CAUSE FOR THE REPORTED FAILURE WAS DETERMINED TO BE DUE TO CUSTOMER DAMAGE.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE DEVICE'S CASE WAS BROKEN AFTER FALLING OUT OF THE AMBULANCE AND THE CUSTOMER WANTED TO SEND THE DEVICE IN FOR REPAIR. WHEN THE DEVICE WAS RETURNED TO PHYSIO-CONTROL FOR REPAIR, IT WAS OBSERVED THAT THE DEVICE WOULD NOT POWER ON. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA