BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1070353 · Received June 30, 2008

    Report

    Report Number
    3015876-2008-00641
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    January 8, 2007
    Report Date
    June 24, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Removal / Correction Number
    Z-0671-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED BY PHYSIO-CONTROL. THE ROOT CAUSE OF THE REPORTED PROBLEM WAS DETERMINED TO BE DUE TO A FAILURE OF IC CHIP, DESIGNATOR U24, ON THE DIGITAL PCB ASSEMBLY. THE IC WAS CAUSING APPROXIMATELY 174 MICRO AMPS OF LEAKAGE CURRENT. THIS AMOUNT OF LEAKAGE CURRENT WOULD CAUSE THE DEVICE BATTERIES TO BECOME DEPLETED PREMATURELY. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED IN RESPONSE TO FIELD ACTION. WHEN THE DEVICE WAS EVALUATED BY PHYSIO-CONTROL, IT WAS FOUND THAT THERE WAS EXCESSIVE LEAKAGE CURRENT CAUSED BY AN IC CHIP, DESIGNATOR U24, ON THE DIGITAL PCB ASSEMBLY. THE EXCESSIVE LEAKAGE CURRENT WOULD HAVE CAUSED THE BATTERIES TO BECOME DEPLETED PREMATURELY, POSSIBLY RESULTING IN A NON-FUNCTIONAL DEVICE.

    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