BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL-AIR PLUS (115V) BLOWER

    MDR report key: 4270107 · Received November 11, 2014

    Report

    Report Number
    3003312341-2014-00013
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    August 15, 2014
    Report Date
    November 11, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING EVALUATION OF THE UNIT IT WAS DISCOVERED THAT THE POWER CORD WAS DAMAGED WITH EXPOSED BARE WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724932 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