BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 1013285 · Received March 14, 2008

    Report

    Report Number
    3015876-2008-00178
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 16, 2008
    Report Date
    February 19, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED PROPER OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. ROOT CAUSE FOR THE REPORTED INCIDENT WAS USE ERROR. THE DEVICE OPERATING INSTRUCTIONS WARN USERS TO "NOT USE THIS DEVICE IN THE PRESENCE OF FLAMMABLE GASES OR ANESTHETICS. USE CARE WHEN OPERATING THIS DEVICE CLOSE TO OXYGEN SOURCES (SUCH AS BAG-VALVE-MASK DEVICES OR VENTILATOR TUBING). TURN OFF GAS SOURCE OR MOVE SOURCE AWAY FROM PATIENT DURING DEFIBRILLATION."

    Description of Event or Problem · 1

    PARAMEDICS RESPONDED TO A PERSON WITH POSSIBLE MI. THE DEVICE WAS CONNECTED TO THE PATIENT FOR 12 LEAD ECGS. THE CREW WAS PERFORMING 12-LEADS AND TRANSPORTING THE PATIENT TO THE HOSPITAL IN THE AMBULANCE, WHEN THE PATIENT WENT INTO CARDIAC ARREST WITH VENTRICULAR FIBRILLATION. ACCORDING TO THE REPORT, THE DEVICE FAILED TO CHARGE TIMES TWO AND THEN, AFTER THE 3RD SHOCK WAS DELIVERED, THE PATIENT'S SHIRT AND CHEST HAIRS CAUGHT ON FIRE. THE REPORT STATED, THAT OXYGEN WAS BEING DELIVERED TO THE PATIENT WHEN THE SHOCK WAS DELIVERED. THE PATIENT WAS RESUSCITATED AND DELIVERED TO THE HOSPITAL ER. THERE WERE NO REPORTS OF ANY ADVERSE AFFECTS AS A RESULT OF THE DEVICE USE.

    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 UNK