BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK CR(R) PLUS DEFIBRILLATOR

    MDR report key: 3960766 · Received July 28, 2014

    Report

    Report Number
    3015876-2014-00858
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K033275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    SERVICE AND TESTING PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE AND WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL HAS ATTEMPTED TO RETRIEVE THE DEVICE FROM THE CUSTOMER HOWEVER, THE CUSTOMER HAS NOT DECIDED AS TO WHETHER OR NOT THEY WILL RETURN THE DEVICE FOR EVALUATION. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED FAILURE 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) AND WOULD NO LONGER POWER ON. THERE WAS NO REPORT OF ANY PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437731 LIFEPAK CR(R) PLUS DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC CRPLUS

    Patients

    Seq Age Sex Outcome Treatment
    1