BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 3061242 · Received April 16, 2013

    Report

    Report Number
    3015876-2013-00301
    Event Type
    Death
    Date Received
    April 16, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 18, 2013
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE EVENT RECORD DOWNLOAD SHOWED THAT THE DEVICE HAD SEVERAL LOW BATTERY WARNINGS DURING USE. PHYSIO'S CLINICAL SPECIALIST REVIEW OF THE EVENT DETERMINED THE CAUSE FOR THE PROBLEM TO BE USE ERROR; THERE WAS NO EVIDENCE THAT THE DEVICE OPERATOR REPLACED THE BATTERIES AFTER THE REPLACE BATTERY WARNINGS. PHYSIO COMPLETED OTHER UNRELATED DEVICE REPAIRS AND CONFIRMED PROPER DEVICE OPERATION. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    DURING A PATIENT EVENT, IT WAS REPORTED THAT THE DEVICE SHOCKED THE PATIENT SEVEN TIMES AND LOST POWER AFTER ONE HOUR AND THIRTY MINUTES OF USE. THE RESPONDERS INITIALLY RECEIVED A CALL FOR A SEIZURE BUT THE PATIENT CONDITION CHANGED TO NOT BREATHING THEREAFTER. THE PATIENT HUSBAND PROVIDED CPR UNTIL THE AMBULANCE CREW ARRIVED AT THE SCENE 10 MINUTES LATER. THE CREW PROVIDED CARE TO THE PATIENT ONSITE FOR ONE HOUR AND 20 MINUTES. DURING TRANSPORT TO MEDICAL FACILITY, THE DEVICE LOST POWER AND THE PATIENT WAS IMMEDIATELY TRANSFERRED TO A PHILIPS AED IN THE AMBULANCE. THE PATIENT RECEIVED TWO ADDITIONAL SHOCKS FROM THE AED. THE DELAY IN SWITCHING DEVICES WAS REPORTED TO BE MINIMAL BUT UNSPECIFIED. THE LIFEPAK 12 DEVICE WAS REPORTED TO HAVE FULLY CHARGED BATTERIES INSTALLED. THE PATIENT WAS PRONOUNCED DECEASED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162713 LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR