BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR PLUS DEFIBRILLATOR

    MDR report key: 2221805 · Received August 17, 2011

    Report

    Report Number
    3015876-2011-00607
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Report Date
    July 22, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K011144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. PHYSIO ANTICIPATES THE DEVICE RETURN TO THE MANUFACTURING FACILITY AND CONTINUES TO INVESTIGATE THE REPORTED PROBLEM. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Description of Event or Problem · 1

    DURING A SCHEDULED INSPECTION, IT WAS REPORTED THAT THE DEVICE DISPLAYED THE CHARGE-PAK, ATTENTION AND WRENCH ICONS AND FAILED TO POWER ON. 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