BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHYSIO CONTROL LIFEPAK 15

    MDR report key: 8155098 · Received December 11, 2018

    Report

    Report Number
    MW5082044
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    December 5, 2018
    Report Date
    December 10, 2018
    Manufacturer
    PHYSIO-CONTROL MAASTRICHT, INC.
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR PLANNED INTUBATION OF PT, THE LIFEPAK 15 MONITOR / DEFIBRILLATOR WAS HOOKED UP TO PT AND TURNED ON. THE MACHINE WOULD POWER ON AND THEN THE DISPLAY SCREEN FOR THE HEART RHYTHM COMES ON WITH LINES ON IT THEN IT FADES TO BLACK AND HAS NO DISPLAY. HAD THE SAME ERROR ON REATTEMPTS TO SEE SCREEN DISPLAY. NO PT HARM OR IMPACT OCCURRED AS ANOTHER MACHINE WAS OBTAINED, AND THIS ONE WAS REMOVED FROM SERVICE. HOWEVER, THE POTENTIAL FOR HARM IS GREAT IF THIS HAD HAPPENED DURING AN ACTUAL CODE / CARDIAC ARREST RESPONSE. SELF TEST ON MACHINE HAS PASSED EVERY DAY AT 0300 AM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990111 PHYSIO CONTROL LIFEPAK 15 AUTOMATED EXTERNAL DEFIBRILLATOR (NON WEARABLE) MKJ PHYSIO-CONTROL MAASTRICHT, INC. LIFE PAK 15

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening