BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 481123 · Received August 28, 2003

    Report

    Report Number
    1217052-2003-00045
    Event Type
    Malfunction
    Date Received
    August 28, 2003
    Date of Event
    July 1, 2003
    Report Date
    July 28, 2003
    Manufacturer
    PORTEX, INC. BY: GALEMED 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 FACILITY REPORTED THAT WHEN THEY WENT TO ASSEMBLE THE RESUSCITATOR, THEY COULD NOT FIT THE 22MM CONNECTOR OF THE MASK TO THE RESUSCITATOR. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT MANUAL RESUSCITATOR SYSTEM BTM PORTEX, INC. BY: GALEMED CORPORATION NA 030422

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO