BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 1063823 · Received June 19, 2008

    Report

    Report Number
    3015876-2008-00623
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 23, 2008
    Report Date
    May 28, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL IS CONTINUING TO INVESTIGATE THE ISSUE.

    Description of Event or Problem · 1

    PHYSIO CONTROL IS INVESTIGATING INTERMITTENT NO-VOICE FAILURES OF DEVICE SPEAKERS ON THE PRODUCTION LINE.

    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