BEUDAMED
    FDA Adverse Event Summary report: N

    ADULT MANUAL RESUSCITATION BAG

    MDR report key: 28753 · Received November 10, 1995

    Report

    Report Number
    1416980-1995-00070
    Date Received
    November 10, 1995
    Report Date
    November 9, 1995
    Manufacturer
    ENGINEERED MEDICAL SYSTEMS, INC.
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE HAVE BEEN OCCURRENCES OF DIFFICULTY VENTILATING PATIENTS WITH THE USE OF THE RESUSCITATOR BAG AND ALSO HAVING TO DISCONNECT THE BAG FROM THE PT'S ET TUBE IN ORDER FOR THE PT TO EXHALE. A CRITICALLY ILL PT EXPIRED DURING THE USE OF ONE OF THE RESUSCITATOR BAGS. HOWEVER, THE RPTR COMMENTED THAT THEY DID NOT DETERMINE THAT THERE WAS AN ADVERSE PT OUTCOME ASSOCIATED WITH THE USE OF THE BAG AND NO ABNORMALITY IN THE OPERATION OF THE BAG WAS FOUND WHEN IT WAS INSPECTED AFTERWARDS BY THE HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT MANUAL RESUSCITATION BAG RESUSCITATOR BAG BTR ENGINEERED MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *