BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1964187 · Received December 22, 2010

    Report

    Report Number
    3015876-2010-01411
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    September 10, 2010
    Report Date
    November 29, 2010
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL DETERMINED THE CAUSE OF THE MALFUNCTION TO BE A SLIGHTLY OFFSET JACK CONNECTOR, DESIGNATOR J505, ON THE ANALOG PCB ASSEMBLY. THE ISSUE RESULTED IN EVENT CODES IN THE MEMORY AND AN INTERMITTENT LEADS OFF CONDITION. A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD THE WRENCH ICON ILLUMINATED. PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED ISSUE. FURTHERMORE, THE DEVICE WAS NOT ABLE TO DELIVER DEFIBRILLATION THERAPY IN THE OBSERVED CONDITION. THERE WAS NO PT 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