BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1ST RESPONSE RESUSCITATOR, ADULT

    MDR report key: 934653 · Received October 17, 2007

    Report

    Report Number
    1217052-2007-00134
    Event Type
    Injury
    Date Received
    October 17, 2007
    Date of Event
    September 3, 2007
    Report Date
    September 19, 2007
    Manufacturer
    MFG FOR SMITHS MED ASD,INC. BY GALE MED CORP.
    Product Code
    BTM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ALLEGES, RESUSCITATOR WAS BEING USED DURING A CODE. NOTICED THAT UNABLE TO VENTILATE THE PT SUFFICIENTLY. DETACHED THE BAG FROM THE ENDOTRACHEAL TUBE AND THE PT WAS THEN ABLE TO EXHALE. ASSUMED THE PT'S ENDOTRACHEAL TUBE WAS THE PROBLEM AND SUCTIONED LARGE AMOUNTS OF MUCOUS, BUT ALSO NOTED THAT, THE ENDOTRACHEAL TUBE WAS NOT PLUGGED AT THIS TIME. CLINICIAN CONTINUED TO TRY TO VENTILATE AND NOTED AUTO PEEP WAS OCCURRING (THERE WAS NO PEEP VALVE ATTACHED). CLINICIAN HAD TO MANUALLY DETACH THE BAG FROM THE ET TO LET THE PT EXHALE. USED A DIFFERENT BRAND RESUSCITATOR AND WAS ABLE TO VENTILATE THE PT WITH NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1ST RESPONSE RESUSCITATOR, ADULT 73 BTM - MANUAL RESUSCITATOR SYSTEM BTM MFG FOR SMITHS MED ASD,INC. BY GALE MED CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention DIFFERENT BRAND RESUSCITATOR| ET TUBE