BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL AIR-PLUS

    MDR report key: 4062551 · Received August 18, 2014

    Report

    Report Number
    4062551
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 18, 2014
    Manufacturer
    STRYKER MEDICAL
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MASKING TAPE FOUND ON PATIENT WARMER WRAPPED AROUND HOSING. TAPE CAUGHT FIRE AND WAS IMMEDIATELY PUT OUT. NO HARM TO PATIENT OR PERSONNEL. WARMER REMOVED FROM SERVICE.FROM BIO-MED: STRYKER MODEL MA1100-PM (MISTRAL AIR) IS THE DEVICE WE NOTED THAT NEARLY STARTED A FIRE. WHAT APPEARED TO HAPPEN WAS THERE HAD BEEN A SPLIT IN THE HEATER HOSE, WHICH STAFF PLACED SOME TAPE ON IT TO SEAL THE AIR. THAT TAPE ACTED AS THE COMBUSTIBLE MATERIAL WHICH THEN CAUSED THE PURPLE PLASTIC TO MELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496391 MISTRAL AIR-PLUS SYSTEM, THERMAL REGULATING DWJ STRYKER MEDICAL MA1100-PM *

    Patients

    Seq Age Sex Outcome Treatment
    1 * NO.