BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 502643 · Received December 10, 2003

    Report

    Report Number
    1217052-2003-00082
    Event Type
    Malfunction
    Date Received
    December 10, 2003
    Date of Event
    November 1, 2003
    Report Date
    November 10, 2003
    Manufacturer
    GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT RESUSCITATOR SYSTEM BTM GALEMED CORPORATION NA 030721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA