BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR ADULT

    MDR report key: 584434 · Received March 18, 2005

    Report

    Report Number
    1217052-2005-00026
    Event Type
    Malfunction
    Date Received
    March 18, 2005
    Report Date
    February 25, 2005
    Manufacturer
    SMITHS MEDICAL ASD, INC. BY: GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THAT HAD THREE EVENTS OF A RESUSCITATOR MISSING THE FACE MASKE. NO ADVERSE EVENT REPORTED.

    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: GALEMED CORPORATION NA 040531

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO