BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS, INC.

    MDR report key: 78753 · Received January 8, 1997

    Report

    Report Number
    78753
    Event Type
    Malfunction
    Date Received
    January 8, 1997
    Date of Event
    August 5, 1996
    Report Date
    August 27, 1996
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    BTM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CODE SITUATION, O2 TUBING TO THE MANUAL RESUSCITATOR BECAME DISCONNECTED AND PT DESATURATED. THE PT WAS PLACED BACK ON THE VENTILATOR. THE O2 TUBING WAS RECONNECTED TO THE MANUAL RESUSCITATOR. WHEN THE PT WAS MANUALLY VENTILATED AGAIN, THE O2 SAT DROPPED WITH THE TUBING CONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGNS, INC. MANUAL RESUSCITATOR BTM VITAL SIGNS, INC. * 191G

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Other