BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 529995 · Received March 3, 2004

    Report

    Report Number
    1217052-2004-00014
    Event Type
    Malfunction
    Date Received
    March 3, 2004
    Report Date
    February 3, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC./GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS DISTRIBUTOR ALLEGES THAT, DURING AN AUDIT OF THEIR INVENTORY THEY HAD ELEVEN MASKS THAT COULD NOT BE FIT TO THE RESUSCITATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT MANUAL RESUSCITATOR SYSTEM BTM SMITHS MEDICAL ASD, INC./GALEMED CORPORATION NA 030721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA