BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL-AIR PLUS (115V) BLOWER

    MDR report key: 4169096 · Received July 25, 2014

    Report

    Report Number
    3003312341-2014-00005
    Event Type
    Malfunction
    Date Received
    July 25, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 24, 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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS REPLACED FOR THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MISTRAL AIR UNIT HAS HIGH CURRENT LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436662 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