BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 518771 · Received February 9, 2004

    Report

    Report Number
    1217052-2004-00006
    Event Type
    Malfunction
    Date Received
    February 9, 2004
    Date of Event
    January 9, 2004
    Report Date
    January 12, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC. BY GALEMD CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGES THAT WHEN STOCKING SHELVES IN THE SUPPLY ROOM THEY NOTICED THAT THE MASK CONNECTION WAS OVAL SHAPED (ON TWO UNITS) AND APPEARED THAT IT WILL NOT FIT ONTO THE RESUSCITATOR BAG CONNECTION. NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT MANUAL RESUSCITATOR SYSTEM BTM SMITHS MEDICAL ASD, INC. BY GALEMD CORPORATION NA 030422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA