BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR

    MDR report key: 2922391 · Received January 18, 2013

    Report

    Report Number
    3015876-2013-00054
    Event Type
    Injury
    Date Received
    January 18, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 20, 2012
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    MKJ
    PMA / PMN Number
    K103567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: ZOLL AUTOPULSE NON-INVASIVE CARDIAC SUPPORT PUMP; CON-MED DEFIBRILLATION ELECTRODES. (B)(4). THE CUSTOMER HAS ADVISED PHYSIO-CONTROL THAT THEY ARE AWAITING THE COMPLETION OF A CORONER REPORT AND POLICE INVESTIGATION BEFORE THEY DECIDE WHETHER OR NOT THEY WILL ALLOW PHYSIO TO PERFORM AN EVALUATION ON THE DEVICE, DUE TO THE NATURE OF THE EVENT. THE CUSTOMER ADVISED THAT IF THEY DECIDE TO HAVE THE DEVICE EVALUATED, THEY WILL CONTACT PHYSIO AND ARRANGE FOR THE EVALUATION. CURRENTLY, THE CUSTOMER HAS HAD THE DEVICE LOCKED IN QUARANTINE AND NO FURTHER INFORMATION REGARDING THE STATUS OF THE DEVICE HAS BEEN PROVIDED. THE CAUSE OF THE REPORTED ISSUE HAS NOT BEEN DETERMINED. A CLINICAL EVALUATION OF THE REPORTED EVENT HAS DETERMINED THAT THE DEVICE USE MAY HAVE CONTRIBUTED TO THE REPORTED FIRE AND INJURY TO THE PATIENT, PRIOR TO THEIR DEATH. THIS WAS DETERMINED DUE TO THE DEVICE USE IN CLOSE PROXIMITY TO AN OXYGEN SOURCE. ALSO, THERE ARE MULTIPLE FACTORS THAT COULD HAVE LED TO THE REPORTED FIRE. FACTORS WHICH COULD HAVE CONTRIBUTED TO A FIRE IGNITION COULD BE AN INCOMPLETE DEFIBRILLATION ELECTRODE SEAL, IMPROPER ELECTRODE PLACEMENT OR THE PRESENCE OF ANOTHER SOURCE OF A SPARK.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHYSIO-CONTROL THAT DURING A PATIENT INCIDENT, FOLLOWING A DEFIBRILLATION SHOCK BEING DELIVERED, A FIRE IGNITED IN THE BACK OF THE AMBULANCE WHICH BURNED THE PATIENT'S FACE. THE PATIENT WAS INITIALLY REPORTED TO HAVE HAD A SEIZURE WHEN 911 WAS CALLED. WHEN EMS ARRIVED, THE PATIENT WAS IN CARDIAC ARREST WITH NO VIABLE OR SHOCKABLE ECG RHYTHM. THE DOWNTIME OF THE PATIENT PRIOR TO THE EMS ARRIVAL WAS UNKNOWN. THE EMS TEAM ATTENDED TO THE PATIENT CONSTANTLY UNTIL ARRIVING AT THE HOSPITAL. WHEN AT THE HOSPITAL AND STILL IN THE BACK OF THE AMBULANCE, THE PATIENT'S ECG RHYTHM DEVELOPED INTO A VENTRICULAR FIBRILLATION RHYTHM. THE EMS TEAM CHARGED THE DEVICE TO 200 JOULES AND DELIVERED A DEFIBRILLATION SHOCK. WHEN THE DEFIBRILLATION SHOCK WAS DELIVERED, A FIRE IGNITED WHICH BURNED THE RIGHT SIDE OF THE PATIENT'S FACE AND MELTED THE AMBU BAG. THE EMS TEAM PUT OUT THE FIRE WITH A BAG OF SALINE SOLUTION. WHEN THE FIRE WAS PUT OUT, RESUSCITATION EFFORTS WERE CONTINUED FOR APPROXIMATELY 20 MINUTES UNTIL THE PATIENT WAS PRONOUNCED DECEASED. THE EMS MEDICAL DIRECTOR STATED THAT THE REPORTED FIRE AND DEVICE USE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT, BUT DID NOTE THAT THE PATIENT SUFFERED EITHER 2ND OR 3RD DEGREE BURNS FROM THE FIRE. THE EXACT DEGREE OF THE BURN WAS NOT REPORTED AND THE AUTOPSY REPORT IS NOT AVAILABLE. THE MEDICAL DIRECTOR REPORTED THAT THE EMS CREW WERE USING THIRD PARTY CONMED DEFIBRILLATION ELECTRODES DURING PATIENT CARE AND ALSO, THEY HAD A ZOLL AUTOPULSE NON-INVASIVE CARDIAC SUPPORT PUMP ATTACHED TO THE PATIENT DURING THE EVENT. THE PATIENT WAS RECEIVING THE FULL AMOUNT OF OXYGEN WHEN THE REPORTED FIRE IGNITED AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27450 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR DEFIBRILLATORS, AUTOMATIC, EXTERNAL MKJ PHYSIO-CONTROL, INC 15

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention ZOLL AUTOPULSE NON-INVASIVE CARDIAC SUPPORT PUMP