BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3172979 · Received June 17, 2013

    Report

    Report Number
    3015876-2013-00513
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE CRITICAL EVENT CODE LOGGED IN THE MEMORY BUT THE SERVICE INDICATOR WAS NOT ILLUMINATED. PHYSIO WAS UNABLE TO DUPLICATE THE EVENT CODE AND OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE LOG WAS CLEARED AND IT WAS RETURNED TO THE CUSTOMER FOR USE. A CONCLUSIVE CAUSE FOR THE REPORTED EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    DURING A DAILY INSPECTION, IT WAS REPORTED THAT THE DEVICE SERVICE INDICATOR ILLUMINATED AND REMAINED ON DURING FOUR DEFIBRILLATION CHARGE AND SHOCK CYCLES. THE DEVICE HAD AN EVENT CODE THAT INDICATED A POSSIBLE CRITICAL FAILURE LOGGED IN THE MEMORY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273020 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1