BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1082703 · Received July 23, 2008

    Report

    Report Number
    3015876-2008-00821
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    May 6, 2008
    Report Date
    June 24, 2008
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE INTERNAL BATTERY WAS FOUND TO BE DEPLETED AND THE DEVICE WOULD NOT POWER ON WITH POWER SUPPLY. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DUE TO TIN WHISKER GROWTH ON THE ON/OFF SWITCH FLEX CABLE. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS DISPLAYING THE CHARGE-PAK ICON IN THE READINESS INDICATOR. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK CR PLUS DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC CRPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA