BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 553982 · Received April 29, 2004

    Report

    Report Number
    1217052-2004-00029
    Event Type
    Malfunction
    Date Received
    April 29, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 29, 2004
    Manufacturer
    SMITHS MEDICAL ASD, INC. BY GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER ALLEGES THAT IN USE THEY HAD ONE RESUSCITATOR THAT THE OXYGEN LINE BECAME DISCONNECTED. THERE WAS NO ADVERSE OUT COME REPORTED. THEY ALSO STATED THAT THEY AUDITED THIS LOT AND FOUND ALL OF THE RESUSCITATORS HAD THE OXYGEN LINE DISCONNECTED.

    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 030722

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO