BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 3181280 · Received June 21, 2013

    Report

    Report Number
    3015876-2013-00533
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO REPRODUCE THE REPORTED FAILURE. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SERVICE LED AND THE AUXILIARY POWER INDICATOR LED ILLUMINATED ON THE DEVICE AND THE DEVICE'S DISPLAY TURNED BLACK. THE DEVICE COULD NOT BE USED IN SPITE OF SEVERAL ATTEMPTS. THE USER REPORTED THAT HALF A DAY LATER, THE DEVICE WAS FUNCTIONING NORMALLY. THE DEVICE WAS ABOUT TO BE USED ON A PATIENT FOR MONITORING. HOWEVER THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT. A BACKUP DEVICE WAS USED AND THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282889 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1