BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ST RESPONSE RESUSCITATOR ADULT

    MDR report key: 673763 · Received August 25, 2005

    Report

    Report Number
    1217052-2005-00076
    Event Type
    Malfunction
    Date Received
    August 25, 2005
    Date of Event
    July 22, 2005
    Report Date
    July 27, 2005
    Manufacturer
    ASD, INC. - GALEMED CORPORATION
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES THAT ONE EVENT OF A RESUSCITATOR FACE MASK WAS NOT BEING PROPERLY INFLATED AND COULD NOT BE SEALED ON THE PATIENT'S FACE. ANOTHER MASK OBTAINED AND NOT ADVERSE OUTCOME REPORTED.

    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 030505

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR