BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP VISION

    MDR report key: 3172032 · Received May 11, 2013

    Report

    Report Number
    3172032
    Event Type
    Malfunction
    Date Received
    May 11, 2013
    Date of Event
    February 23, 2013
    Report Date
    May 7, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    INITIAL REPORTER SAID: PT PUT ON VISION BIPAP. A FEW MINUTES AFTER HE'S ON, ER TECH AND I SMELLED A BURNING ODOR, THEN A FEW SECONDS FROM THAT, THE VISION BIPAP EQUIPMENT WENT INOP (INOPERATIVE). WE COULD NOT RESET THE VISION EQUIPMENT TO RUN. PT WAS STAT DISCONNECTED. PT STARTED TO DECOMPENSATE, SATURATION STARTED GOING DOWN. WE STARTED TO BAG THE PT FOR INTUBATION. BIOMED TOOK THE EQUIPMENT TO CHECK. FOLLOW-UP REPORTER SAID: THE BIPAP MACHINE HAD AN ELECTRICAL FIRE (NO ACTUAL FLAMES, JUST THE BURNING SMELL AND AND HEAT - THE MACHINE DID NOT SHUT ITSELF OFF). ACCORDING TO ONE OF THE ED TECHS, THE SMELL HAD BEEN PRESENT YESTERDAY AS WELL AND APPARENTLY HAD NOT BEEN ADDRESSED. WE HAD TO INTUBATE THIS PATIENT EMERGENTLY DUE TO THIS INCIDENT AS HE WAS NOT ABLE TO TOLERATE BEING OFF THE BIPAP LONG ENOUGH TO GET ANOTHER MACHINE. FINALLY, AFTER REPAIR: UPON INCOMING INSPECTION AND TESTING, THE DEVICE DEMONSTRATED THE SAME CONCERN AS THAT DURING THE INCIDENT.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?VENTILATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209882 BIPAP VISION VENTILATOR, BIPAP MNT RESPIRONICS, INC. BIPAP VISION *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR