BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK(R) 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2832143 · Received November 14, 2012

    Report

    Report Number
    3015876-2012-00843
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 18, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K102972
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL'S CLINICAL REVIEW OF THE REPORTED EVENT DETERMINED THAT THE DEVICE USE MAY HAVE CONTRIBUTED TO AN ADVERSE EVENT AS THE OPERATOR FAILED TO CONFIRM THE SYNC MARKERS APPROPRIATE PLACEMENT PRIOR TO TREATMENT, USE ERROR. THE EVENT RECORD ECG DOWNLOAD SHOWED THAT THE DEVICE USER INAPPROPRIATELY DELIVERED A SYNCHRONIZED SHOCK WHEN THE SYNC MARKERS WERE ON THE T-WAVES RATHER THAN ON THE QRS COMPLEX. PER THE DEVICE OPERATING INSTRUCTIONS, THE OPERATOR SHOULD EVALUATE THE PATIENT ECG AND CONFIRM THE SYNC SENSE MARKERS PLACEMENT NEAR THE MIDDLE OF EACH QRS COMPLEX. IF THE SENSE MARKERS ARE PLACED IN THE WRONG LOCATION, THE OPERATOR IS INSTRUCTED TO CORRECT THE PLACEMENT BY EITHER SELECTING DIFFERENT ECG LEADS OR INCREASING THE ECG SIZE PRIOR TO TREATMENT. PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED NO DEVICE FAILURES. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND THE DEVICE RETURNED TO THE CUSTOMER FOR USE. PHYSIO-CONTROL FOLLOWED UP WITH THE CUSTOMER REGARDING THE INVESTIGATION RESULTS AND CONFIRMED THAT THE FACILITY WAS AWARE THAT THE INCIDENT WAS A RESULT OF USER ERROR. THE CUSTOMER WAS AWARE OF THE OPERATING INSTRUCTION FOR SYNCHRONIZED CARDIOVERSION AND WILL PROVIDE ANY ADDITIONAL INTERNAL CLINICAL TRAINING IF DEEMED NECESSARY.

    Description of Event or Problem · 1

    DURING A SYNCHRONIZED CARDIOVERSION TREATMENT, IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK ON THE T-WAVE AND WAS INDUCED TO A VENTRICULAR FIBRILLATION ECG RHYTHM. THE PATIENT WAS SUBSEQUENTLY DEFIBRILLATED ASYNCHRONOUSLY AND CONVERTED TO A NON-SHOCKABLE ECG RHYTHM. THE PATIENT WAS REPORTED TO BE RECOVERING AFTER THE INCIDENT.

    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 44 YR Life Threatening| R