BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12

    MDR report key: 1221106 · Received October 26, 2008

    Report

    Report Number
    1221106
    Event Type
    Malfunction
    Date Received
    October 26, 2008
    Date of Event
    September 15, 2008
    Report Date
    October 26, 2008
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEFIBRILLATOR FAILED TO FIRE. DEVICE SAID SERVICE WHEN NURSE PUSHED "SHOCK" DEVICE WAS FULLY CHARGED TO 360 JOULES. NURSE TURNED DEVICE OFF AND RECHARGED TO 360 JOULES AND DEFIBRILLATOR THEN DELIVERED. PATIENT WAS IN VENTRICULAR FIBRILLATION. DEFIB WAS TURNED OFF AND BACK ON WHICH REMEDIED THE PROBLEM. FORTUNATELY THE PATIENT DID NOT HAVE AN ADVERSE OUTCOME. THIS INCIDENT IS VERY SIMILAR TO ONE THAT HAPPENED ROUGHLY 2 YEARS AGO WHERE THE DEFIBRILLATOR FILLED UP ITS MEMORY AND WOULD NOT DELIVER A SHOCK. AT THAT TIME IT WAS DECIDED THAT ALL OF OUR DEFIBRILLATOR SETTINGS WOULD BE CHANGED TO NOT RECORD VITALS AND THEREFORE NOT FILL UP THE MEMORY THEREBY ELIMINATING THIS POSSIBLE MALFUNCTION. WITH THE MOVE TO THE NEW LIFEPAK 12S WHICH WERE PURCHASED, THESE NEW DEFIBS DID NOT GET THE SETTINGS CHANGED TO NOT RECORD VITALS. CURRENTLY BIOMED IS STILL IN DIRECT CONTACT WITH THE MANUFACTURER, AND WAITING FOR FURTHER INFORMATION, IN REGARDS TO THE MEANING OF SOME ERROR LOGS, AND THE "CONTINUOUS ECG RECORDING ."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR LDD PHYSIO-CONTROL, INC. LP12 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR