BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2428086 · Received January 25, 2012

    Report

    Report Number
    3015876-2012-00061
    Event Type
    Death
    Date Received
    January 25, 2012
    Date of Event
    December 28, 2011
    Report Date
    December 29, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    EMERGENCY MEDICAL TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO VERIFY THE REPORTED FAILURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS SUBSEQUENTLY RETURNED TO THE CUSTOMER FOR USE. A CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT A DEVICE USE ERROR WAS RELATED TO THE REPORTED EVENT. THE CUSTOMER REPORTED THAT THERE WAS INADEQUATE SKIN PREOPERATION PERFORMED ON THE PATIENT PRIOR THE APPLICATION OF THE DEFIBRILLATION ELECTRODES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PATIENT EVENT, THE DEVICE DID NOT RECOGNIZE THE PATIENT, WHEN CONNECTED. THE CUSTOMER REPORTED THAT THE MEDIC WHOM WAS ATTENDING TO THE PATIENT, DID NOT PERFORM ADEQUATE SKIN PREPARATION AND THE PATIENT DID HAVE A VERY HAIRY CHEST. THE MEDIC DID INITIALLY ATTACH THE DEFIBRILLATION ELECTRODES TO THE PATIENT AND WHEN THE DEVICE DID NOT DETECT THE PATIENT, THE MEDIC REMOVED THE ELECTRODES, SHAVED THE PATIENT'S CHEST, AND THEN RE-APPLIED THE SAME ELECTRODES. THE DEVICE STILL DID NOT DETECT A PATIENT CONNECTION. THE MEDIC DID NOT HAVE AN ADDITIONAL SET OF ELECTRODES TO CONNECT TO THE PATIENT. THE PATIENT WAS TRANSFERRED TO THE LOCAL HOSPITAL; HOWEVER THEY DID NOT SURVIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death