BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3970567 · Received July 31, 2014

    Report

    Report Number
    3015876-2014-00876
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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 IDENTIFIED THAT THIS DEVICE WAS REMANUFACTURED WITHOUT THE INVOLVEMENT OF PHYSIO-CONTROL. THEREFORE, PHYSIO-CONTROL IS NO LONGER THE MANUFACTURER AND NO ADDITIONAL INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THEY POWER THEIR DEVICE ON, THE DISPLAY STARTS FLASHING AND THE DEVICE LOCKS UP. IN THIS CONDITION, THE DEVICE COULD NOT BE USED FOR DEFIBRILLATION THERAPY IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447745 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1