BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHYSIOCONTROL LP15

    MDR report key: 1737967 · Received June 23, 2010

    Report

    Report Number
    MW5016482
    Event Type
    Death
    Date Received
    June 23, 2010
    Date of Event
    June 21, 2010
    Report Date
    June 23, 2010
    Product Code
    MKJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BASICALLY WE WERE DISPATCHED ALONG WITH (B)(6) FOR A WORKING CODE AT (B)(6). ON ARRIVAL THE PT'S CARETAKERS HAD INITIATED CPR. I IMMEDIATELY HAD MY CREW TAKE OVER CPR AND PLACED THE PT ON THE MONITOR. THE INITIAL RHYTHM WAS V-FIB. I ADVISED WE NEEDED TO SHOCK THE PT AND HIT THE ENERGY SELECT BUTTON AT LEAST 20 TIMES WITH NO REACTION. I SHUT THE MONITOR OFF AND RESTARTED IT HOPING TO SOLVE THE PROBLEM AND IT DID NOT. I COULD NOT SELECT AN ENERGY TO CHARGE TO. AFTER REPEATED FAILED ATTEMPTS BY BOTH MYSELF AND (B)(6) WE CONTINUED CPR TO THE MEDIC UNIT AND I HAD (B)(6) CREW GET ME THEIR LP12. WE CONTINUED CPR, THE PT THEN WENT INTO ASYSTOLE BEFORE I COULD GET THE LP12 HOOKED UP TO DELIVER A SHOCK. IV, ET INTUBATION, MEDICATION ADMINISTRATION PER PROTOCOL AND TRANSPORT TO (B)(6) ER WITH CPR THROUGHOUT. AFTER CARE WAS TRANSFERRED TO THE ER STAFF (B)(6) CONTACTED EMS (B)(6) WHO MADE HIS WAY TO THE ER TO EVALUATE THE MONITOR. WE RECREATED THE PROBLEM AT LEAST 10 TIMES. WE EVENTUALLY GOT THE MONITOR TO SELECT AN ENERGY, BUT THEN WE COULD NOT CHANGE THE ENERGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOCONTROL LP15 LIFEPAK15 MKJ LP15

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death