BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 922055 · Received October 1, 2007

    Report

    Report Number
    3015876-2007-00369
    Event Type
    Malfunction
    Date Received
    October 1, 2007
    Report Date
    September 6, 2007
    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, INC. EVALUATED THE DEVICE. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A FAILURE OF THE SPEAKER ASSEMBLY. AFTER REPLACING THE SPEAKER ASSEMBLY, PROPER OPERATION WAS CONFIRMED AND THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD NO AUDIO OUTPUT. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED 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 YR