BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 567200 · Received January 12, 2005

    Report

    Report Number
    1217052-2005-00005
    Event Type
    Malfunction
    Date Received
    January 12, 2005
    Report Date
    December 15, 2004
    Manufacturer
    ASD, INC, GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THAT A RESUSCITATOR WAS MISSING THE FACE MASK. THIS SAMPLE HAD BEEN OPENED BUT THEY ALLEGE THIS IS NOT THE FIRST TIME THIS HAS HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT MANUAL RESUSCITATOR SYSTEM BTM ASD, INC, GALEMED CORPORATION NA 040609

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO