BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS MEDICAL SYSTEMS VENTILATOR

    MDR report key: 35898 · Received August 12, 1996

    Report

    Report Number
    35898
    Event Type
    Injury
    Date Received
    August 12, 1996
    Date of Event
    August 5, 1996
    Report Date
    August 6, 1996
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL GRP.
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    RESPIRATORY THERAPIST NOTICED THE NURSE WAS HAVING DIFFICULTY MAINTAINING THE PT'S BLOOD PRESSURE. THE THERAPIST MENTIONED TO THE NURSE THAT THE PT WAS ON +5 PEEP, AND A DECISION WAS MADE TO DISCONTINUE IT. AS THE KNOB ON THE MACHINE WAS DECREASED FROM 5 TO 0, THE PRESSURE MANOMETER ROSE UP TO 20 OF PRESSURE. THE PT WAS TAKEN OFF THE VENTILATOR AND IMMEDIATELY VENTILATED MANUALLY WITH 100% OXYGEN. THE MANOMETER ON THE MACHINE FELL TO 0. THE THERAPIST CHECKED OVER THE MACHINE AND EVERYTHING APPEARED IN ORDER. THE MACHINE WAS THEN PLACED ON THE PT AGAIN, AND THE MANOMETER ROSE TO 20. THE MACHINE WAS REMOVED IMMEDIATELY, AND THE PT WAS PLACED ON ANOTHER. THE PT IS CURRENTLY UNSTABLE, AND BEING TREATED FOR AN AIR EMBOLIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS MEDICAL SYSTEMS VENTILATOR VENTILATOR CBK SIEMENS MEDICAL SYSTEMS, INC. ELECTROMEDICAL GRP. SERVO 900 C *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R
    2