BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 502675 · Received December 10, 2003

    Report

    Report Number
    1217052-2003-00079
    Event Type
    Malfunction
    Date Received
    December 10, 2003
    Date of Event
    November 1, 2003
    Report Date
    November 12, 2003
    Manufacturer
    SMITHS MEDICAL ASD, INC., GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY ALLEGES THAT WHEN THEY WENT TO USE A RESUSCITATOR THEY COULD NOT ATTACH THE FACE MASK TO THE RESUSCITATOR. NO ADVERSE OUTCOME TO PATIENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO