BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1190591 · Received October 3, 2008

    Report

    Report Number
    3015876-2008-01456
    Event Type
    Malfunction
    Date Received
    October 3, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO REPLACED THE ANALOG PCB ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO-CONTROL FURTHER EVALUATED THE REPLACED ASSEMBLY, AND DETERMINED THAT THE ROOT CAUSE OF THE REPORTED FAILURE WAS A LEAKY CAPACITOR, DESIGNATOR C177. THE CUSTOMER RECEIVED A REPLACEMENT DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED THE CHARGE-PAK, ATTENTION, AND SERVICE WRENCH ICONS AND WOULD NOT POWER ON. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORT.

    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