BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK(R) 1000 DEFIBRILLATOR

    MDR report key: 3250862 · Received July 29, 2013

    Report

    Report Number
    3015876-2013-00669
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    June 25, 2013
    Report Date
    July 4, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K042404
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED FAILURE. PHYSIO OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PATIENT INCIDENT, THE DEVICE WOULD NOT READ THE PATIENT'S ECG WHEN CONNECTED WITH THE DEFIBRILLATION ELECTRODES. THE PATIENT'S DOWNTIME PRIOR TO EMS ARRIVAL WAS NOT REPORTED. FOLLOWING THE REPORTED FAILURE OF THE DEVICE TO RECOGNIZE THE PATIENT'S ECG RHYTHM, A BACK-UP DEVICE ARRIVED APPROXIMATELY 8 MINUTES LATER. THE PATIENT WAS RESUSCITATED AND TRANSPORTED TO THE HOSPITAL. THE PATIENT IS CURRENTLY REPORTED TO BE IN INTENSIVE CARE. THERE WAS NO ADVERSE EFFECT REPORTED TO HAVE BEEN CAUSED TO THE PATIENT AS A RESULT OF THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353862 LIFEPAK(R) 1000 DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR