BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEPACK 20

    MDR report key: 4156408 · Received October 8, 2014

    Report

    Report Number
    4156408
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 23, 2014
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) YR OLD FEMALE COMES INTO THE HOSP BEING PACED DUE TO SEVERE BRADYCARDIA. SHE IS SWITCHED FROM THE EMS PACER TO COVENANT'S PACER MACHINE WHICH PASSED SHIFT CHECKS THE DAY OF THIS EVENT. THE PACER SYSTEM WAS WORKING AND THE PT HAD BEEN ON THE DEVICE FROM 10 - 20 MINS WHEN THE DEVICE PERFORMED A SELF TEST IN THE MIDDLE OF PACING THE PT AND THEN SHUT OFF CAUSING THE PT TO GO INTO CARDIAC ARREST. CPR PERFORMED FOR ABOUT 6 MINS WHEN PULSE OBTAINED AND WAS ABLE TO BE PLACED BACK ON ANOTHER PACER THAT WAS FUNCTIONING PROPERLY. PT WAS INTUBATED FOR A FEW DAYS AND NOW IS OFF THE VENTILATOR AND HAS HAD A PERMANENT PACEMAKER PLACED. IF THE INITIAL PACER DEVICE WOULD HAVE CONTINUED TO PACE THE PT WOULD NOT HAVE CODED. DEVICE IS AVAILABLE AT COVENANT FOR MANUFACTURER TO CHECK BUT NOT RELEASABLE AT THIS TIME TO RETURN TO THE COMPANY. OUR BIOMED HAS BEEN IN CONTACT WITH PHYSIO-CONTROL CONCERNING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630854 LIFEPACK 20 DEFIBRILLATOR LDD PHYSIO-CONTROL, INC. LIFEPAK 20

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening