BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL AIR PLUS (115V) BLOWER

    MDR report key: 4062553 · Received August 18, 2014

    Report

    Report Number
    4062553
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 15, 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

    STRYKER MODEL MA1100-PM (MISTRAL AIR) IS THE DEVICE THAT WAS SENT TO BIOMED WITH THE FRONT CASE FALLING OFF THE UNIT. THIS PHYSICAL PROBLEM IS A RATHER FREQUENTLY NOTED ONE WHERE WE ARE CAUSED TO SEND THE UNIT BACK TO THE MANUFACTURER FOR EXCHANGE. WITH THIS DEVICE, WE NOTICED MORE SPLITS IN THE HOSE AND ANOTHER MELT SPOT. THIS TOO APPEARS TO HAVE HAD THE OPPORTUNITY TO BE A FIRE STARTER. WITH THIS DEVICE, WE ALSO NOTED MANY OTHER TEARS IN THE UNIT THAT BEGAN TO MELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495395 MISTRAL AIR PLUS (115V) BLOWER SYSTEM, THERMAL REGULATING DWJ STRYKER MEDICAL MA1100-PM *

    Patients

    Seq Age Sex Outcome Treatment
    1 *