BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2141343 · Received June 1, 2011

    Report

    Report Number
    3015876-2011-00428
    Event Type
    Malfunction
    Date Received
    June 1, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K082937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. IT WAS OBSERVED THAT THE DEVICE WOULD FAIL TO DELIVER ENERGY. PHYSIO DETERMINED THAT THE CAUSE OF THE REPORTED FAILURE WAS DUE TO A TWO-PIN CONNECTOR FROM THE ISOLATION RELAY COIL, WHICH WAS NOT FULLY SEATED INTO THE MATING CONNECTOR, DESIGNATOR J22 ON THE THERAPY PCB ASSEMBLY. AFTER FULLY SEATING, THE CONNECTOR TO THE THERAPY PCB ASSEMBLY, PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING, AND THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. A CLINICAL EVALUATION DETERMINED THAT THE DEVICE USE DID NOT CONTRIBUTE TO THE OUTCOME OF THE PT AS DEFIBRILLATION WAS DELAYED LESS THEN A MIN AND ON-GOING CPR WAS PROVIDED. THREE SHOCKS WITHIN 1 MIN AND 8 SECONDS OF EACH OTHER WERE ATTEMPTED. THE FIRST ABNORMAL SHOCK WAS DELIVERED A WIDE COMPLEX TACHYCARDIA, WHICH APPEARED TO CONTINUE AFTER THE SHOCK. A SECOND ABNORMAL SHOCK WAS DELIVERED TO AN IRREGULAR, BUT ORGANIZED TACHYCARDIC RHYTHM, WHICH APPEARED TO BECOME MORE ORGANIZED AFTER THE ATTEMPTED SHOCK. HOWEVER, CPR WAS STARTED IMMEDIATELY, SO IT IS TOO DIFFICULT TO ASCERTAIN THE TRUE ECG RHYTHM AFTER THE ATTEMPTED SHOCK. REGARDLESS, THE PT'S RHYTHM CONVERTED SPONTANEOUSLY TO A NON-SHOCKABLE ECG PRIOR TO THE ATTEMPTED 3RD SHOCK. THE PT REMAINED IN A NON-SHOCKABLE RHYTHM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRE DEPARTMENT PARAMEDICS WERE CALLED TO A (B)(6) FEMALE WHO HAD COLLAPSED. UPON ARRIVAL, THE PT WAS FOUND TO HAVE AGONAL RESPIRATIONS WITH NO PALPABLE PULSE AND WAS COLD TO THE TOUCH. THE PT'S INITIAL ECG RHYTHM WAS DIAGNOSED AS ASYSTOLE. AFTER APPROX 18 MINS OF CPR AND DRUG THERAPY, THE PT'S RHYTHM CHANGED TO FINE VENTRICULAR FIBRILLATION AND DEFIBRILLATOR SHOCKS WERE ATTEMPTED. THE DEVICE REPORTEDLY DISPLAYED A "SHOCK ABNORMAL" WARNING MESSAGE EACH TIME A SHOCK WAS ADMINISTERED AND IT DID NOT APPEAR THAT THE PT RECEIVED ANY ENERGY. THE PT WAS TRANSPORTED TO THE HOSPITAL AND TRANSFERRED TO THE ICU DEPARTMENT WITH A HEART RATE; HOWEVER, IT WAS LATER REPORTED THAT THE PT EXPIRED 7 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 15 MONITOR/DEFIBRILLATOR MKJ PHYSIO-CONTROL, INC 15 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR