BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE MANUAL RESUSCITATOR, ADULT

    MDR report key: 440812 · Received January 30, 2003

    Report

    Report Number
    1217052-2003-00012
    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
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING SERVERAL DIFFERENT CODE SITUATIONS THE RESUSCITATOR WAS ALLEGEDLY MISSING THE MASK. THEY OBTAINED ANOTHER RESUSCITATOR AND NO PATIENT COMPROMISE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO