BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 RESPONSE RESUSCITATOR, ADULT

    MDR report key: 558274 · Received May 8, 2004

    Report

    Report Number
    1217052-2004-00035
    Event Type
    Malfunction
    Date Received
    May 8, 2004
    Report Date
    April 8, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC., GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGES THAT THEY COULD NOT FIT THE FACE MASK TO THE RESUSCITATOR AS IT WAS MIS-SHAPEN. THERE WAS NO ADVERSE OUT COME REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO