BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 2050109 · Received April 5, 2011

    Report

    Report Number
    3015876-2011-00299
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 8, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT THE DEVICE ILLUMINATED ALL THREE ICONS AND FAILED TO POWER ON. PHYSIO DETERMINED THE CAUSE OF THE MALFUNCTION TO BE A SHORTED CAPACITOR, DESIGNATOR C134, ON THE ANALOG PCB ASSEMBLY. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING A SCHEDULED INSPECTION, IT WAS REPORTED THAT THE DEVICE HAD ALL THREE (CHARGE-PAK, ATTENTION AND WRENCH) ICONS ILLUMINATED. THE REPORTED ISSUE COULD BE AN INDICATIVE OF THE DEVICE FAILURE TO POWER ON. THERE WAS NO REPORT OF PATIENT USE ASSOCIATED WITH THE 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