BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE MANUAL RESUSCITATOR

    MDR report key: 440803 · Received January 30, 2003

    Report

    Report Number
    1217052-2003-00010
    Event Type
    Malfunction
    Date Received
    January 30, 2003
    Date of Event
    December 1, 2002
    Report Date
    December 31, 2002
    Manufacturer
    PORTEX, INC. BY GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY ALLEGES THAT THE 22MM ID CONICAL FITTING OF THE MASK COULD NOT BE ATTACHED TO THE RESUSCITATOR DURING A CODE SITUATION. NO PATIENT COMPROMISE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE MANUAL RESUSCITATOR ADULT MANUAL RESUSCITATOR SYSTEM BTM PORTEX, INC. BY GALEMED CORPORATION NA 020622

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO