BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR

    MDR report key: 3222664 · Received July 12, 2013

    Report

    Report Number
    3015876-2013-00609
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K052057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL PROVIDED TECHNICAL ASSISTANCE TO THE BIOMED. IT WAS LATER CONFIRMED BY THE BIOMED THAT DUE TO THE AGE OF THE DEVICE AND THE COST ASSOCIATED WITH REPAIR THAT THEY HAVE ELECTED TO RETIRE THE UNIT AND PERMANENTLY REMOVE IT FROM SERVICE. THE CUSTOMER WILL DISPOSE OF IT LOCALLY. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER, A BIOMED, CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD A SERVICE WRENCH PRESENT ON THE DISPLAY AND AN EVENT CODE IN THE MEMORY. THE EVENT CODE IN THE MEMORY INDICATES THAT THE DEVICE WOULD NOT LIKELY BE ABLE TO PROVIDE SUFFICIENT DEFIBRILLATION THERAPY, IF NEEDED. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323572 BIPHASIC LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1