BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 5123987 · Received October 2, 2015

    Report

    Report Number
    3015876-2015-01207
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 8, 2015
    Report Date
    October 2, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER HAS ADVISED PHYSIO-CONTROL THAT THEY HAVE DECIDED TO NOT RETURN THE DEVICE TO PHYSIO-CONTROL FOR EVALUATION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR DEVICE WAS SHOWING ALL THREE ICONS (ATTENTION, SERVICE WRENCH AND CHARGE-PAK). WITH THIS DEVICE INDICATING ALL THREE ICONS, THERE IS LIKELY AN INTERNAL POWER ISSUE WHICH COULD AFFECT THE DELIVERY OF DEFIBRILLATION ENERGY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653197 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1