BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL-AIR PLUS (115V) BLOWER

    MDR report key: 4284140 · Received October 1, 2014

    Report

    Report Number
    3003312341-2014-00011
    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 THE UNIT WAS FOUND TO HAVE BLACKENING ON THE INTERIOR AND EXTERIOR OF THE HOSE. THE UNIT WAS REMOVED FROM USE. NO PT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610216 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