BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 15

    MDR report key: 5049039 · Received August 27, 2015

    Report

    Report Number
    MW5055860
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    August 22, 2015
    Report Date
    August 27, 2015
    Manufacturer
    PHYSIO CONTROL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NARRATIVE FROM PPCR: ACCORDING TO JAIL STAFF, PATIENT LAST SEEN ALIVE AROUND 2230 LAST NIGHT. ON M110 ARRIVAL, PATIENT SUPINE ON FLOOR WITH JAIL STAFF DOING CPR USING AEDS. JAIL'S AED WAS ANALYZING ON OUR ARRIVAL BUT DID NOT ADVISE A SHOCK. WE MOVED HIM TO OUR LIFEPAK WHERE HE WAS IN ASYSTOLE. CONTINUED CPR. INTUBATED AND STARTED IV. BGL-253. MOVED TO LUCAS AND THEN TO MEDIC UNIT. DURING TRANSPORT GAVE 3 MG EPI AND 300 MG AMIODARONE. DURING LAST 2 RHYTHM CHECKS PATIENT IN V FIB. ATTEMPTED TO DEFIBRILLATE APPROX. 7 TIMES BUT THE LIFEPAK WOULD NOT CHARGE COMPLETELY. APPLIED NEW DEFIB PADS AND TURNED MACHINE OFF AND ON AGAIN, BUT LIFEPAK STILL WOULD NOT DEFIBRILLATE. NO OTHER CHANGES EN ROUTE. AFTER INVESTIGATION BY PHYSIO, THE LIFEPAK WAS FOUND TO HAVE A MALFUNCTION TO ONE OF THE CAPACITORS ON THE THERAPY BOARD. THE CAPACITOR WAS DETACHED COMPLETELY LEADING TO BELIEVE THAT THE UNIT MAY HAVE BEEN DROPPED. MORE TO COME ON THIS FROM PHYSIO HQ AND POST MARKET SURVEILLANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569724 LIFEPAK 15 EXTERNAL DEFIBRILLATOR MKJ PHYSIO CONTROL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other