BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MISTRAL AIR PLUS (115V) BLOWER

    MDR report key: 4234894 · Received September 8, 2014

    Report

    Report Number
    3003312341-2014-00006
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 12, 2014
    Report Date
    September 8, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS SENT TO THE DISTRIBUTOR FOR EVAL. A REPLACEMENT UNIT WAS SENT TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHERE THE HOSE MEETS THE UNIT, IT LOOKS LIKE THE UNIT BURNED HOLES IN THE HOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549220 MISTRAL AIR PLUS (115V) BLOWER DWJ THE SURGICAL COMPANY INTERNATIONAL BV DBA THE 37COMPANY MA1100-PM

    Patients

    Seq Age Sex Outcome Treatment
    1