BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL-AIR PLUS (115V) BLOWER

    MDR report key: 4200922 · Received September 18, 2014

    Report

    Report Number
    3003312341-2014-00007
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 18, 2014
    Manufacturer
    THE SURGICAL COMPANY INTERNATIONAL BV DBA
    Product Code
    DWJ
    PMA / PMN Number
    K101705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED THIS UNIT FOR EVALUATION AND WAS SENT A REPLACEMENT UNIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAD BURN MARKS WHERE THE HOSE ATTACHES TO THE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580017 MISTRAL-AIR PLUS (115V) BLOWER THERMAL REGULATING DWJ THE SURGICAL COMPANY INTERNATIONAL BV DBA MA1100-PM

    Patients

    Seq Age Sex Outcome Treatment
    1