BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1062168 · Received June 13, 2008

    Report

    Report Number
    3015876-2008-00607
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 19, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND COULD NOT CONFIRM OR REPLICATE THE REPORTED EVENT. PHYSIO OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. PHYSIO FURTHER EVALUATED THE THERAPY CABLES THROUGH DESTRUCTIVE TESTING, AND OBSERVED NO DISCREPANCIES. ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    PARAMEDICS RESPONDED TO A WITNESSED CARDIAC ARREST IN A WORKPLACE SETTING WHERE FIRST RESPONDERS WERE ALREADY WORKING PT CONNECTED TO AN AED. THE PT WAS DESCRIBED AS OBESE AND EXTREMELY DIAPHORETIC. THE AED WAS DISCONNECTED FROM THE ELECTRODES AND SWAPPED OUT WITH THE PARAMEDIC'S DEVICE. ACCORDING TO THE RPTR, THE DEVICE ALARMED "CONNECT ELECTRODES" AND WOULD NOT RECOGNIZE THE PT CONNECTION. THE RPTR INDICATED THAT THE PARAMEDICS CHANGED ELECTRODES, X2, BUT CONTINUED TO RECEIVE A "CONNECT ELECTRODES" MESSAGE. THE DEVICE WAS SWAPPED OUT WITH THE AED THAT THEN WAS USED TO DELIVER 2 SHOCKS. THE PT WAS LOADED INTO THE AMBULANCE FOR TRANSPORT. PARAMEDICS SWAPPED OUT THE DEVICE'S THERAPY CABLE WITH ANOTHER AND CONNECTED IT TO THE PT WITH SUCCESS. THE PT WAS TRANSPORTED TO THE HOSP, BUT WAS NOT RESUSCITATED. PHYSIO-CONTROL EVALUATED THE PT EVENT RECORD FROM THE DEVICE AND COULD NOT DETERMINE THE IMPACT OF THE DEVICE USE. UNDERLYING RHYTHM ON NOISY ECG DID NOT APPEAR TO BE A SHOCKABLE RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR QUICK-COMBO PACING/DEFIBRILLATION/ECG ELECTRODES| KENDALL BRAND DISPOSABLE DEFIBRILLATION/ECG| ELECTRODES