BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL-AIR PLUS (115V) BLOWER

    MDR report key: 4284141 · Received October 1, 2014

    Report

    Report Number
    3003312341-2014-00008
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 21, 2014
    Report Date
    October 1, 2014
    Manufacturer
    THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY
    Product Code
    DWJ
    PMA / PMN Number
    K101705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGICAL CASE A MISTRAL AIR UNIT STARTED TO PRODUCE SMOKE AND CAUGHT FIRE WHICH WAS IMMEDIATELY EXTINGUISHED. THE HOSE WAS REPORTED TO HAVE BEEN TAPPED TO REPAIR A SPLIT IN THE HEATER HOSE. THE TAPE WAS REPORTED TO HAVE ACTED AS A COMBUSTIBLE MATERIAL WHICH CAUSED THE PLASTIC TO MELT AT THE HOSE AND DEVICE CONNECTION. THE UNIT WAS REMOVED FROM SERVICE IMMEDIATELY AND NO INJURY TO THE PT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610203 MISTRAL-AIR PLUS (115V) BLOWER THERMAL REGULATING DWJ THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY MA1100-PM

    Patients

    Seq Age Sex Outcome Treatment
    1