BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 488106 · Received October 7, 2003

    Report

    Report Number
    1217052-2003-00063
    Event Type
    Malfunction
    Date Received
    October 7, 2003
    Date of Event
    September 10, 2003
    Report Date
    September 10, 2003
    Manufacturer
    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

    DURING AN AUDIT FOR THE MASK SHAPE, FACILITY HAD THREE UNITS THAT THE 22MM CONNECTOR WAS OUT OF ROUND AND COULD NOT BE FIT TO THE RESUSCITATOR, PRODUCT NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT MANUAL RESUSCITATOR SYSTEM BTM GALEMED CORPORATION NA 030506

    Patients

    Seq Age Sex Outcome Treatment
    1 NA