BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS-ELEMA VENTILATOR

    MDR report key: 35566 · Received June 28, 1996

    Report

    Report Number
    35566
    Event Type
    Injury
    Date Received
    June 28, 1996
    Date of Event
    June 4, 1996
    Report Date
    June 14, 1996
    Manufacturer
    ELECTRO MEDICAL GROUP SIEMENS MEDICAL SYSTEMS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WAS PLACED ON VENTILATOR FOLLOWING CABG ON 6/4/96. RN NOTED PT'S BLOOD PRESSURE BEGINNING TO DROP AND FACE BEGAN TO TURN BLUE AND DUSKY. ABDOMEN INCREASED IN SIDE, CPR WAS STARTED. THE PT WAS AMBU-BAGGED AND HIS COLOR RETURNED. THE PHYSICIAN ORDERED THE VENTILATOR TO BE CHANGED OUT. CLINICAL ENGINEERING TEST REVEALED THE OPERATION TO BE SOMEWHAT ERRATIC WITH THE UNIT DELIVERING SPONTANEOUS BREATHS, TRIGGERED BY A SMALL LEAK IN THE CIRCUIT. THE CIRCUIT WAS TIGHTENED AND OPERATION RESUMED NORMALLY. IT WAS ALSO FOUND THAT THE TRANSDUCER WAS ZEROED WHICH COMBINED WITH A PEEP SETTING OF 5 CM H2O, GAVE A MEAN PRESSURE OF APPROX 23CM H2O. THE UNIT RECENTLY HAD A CALIBRATION AND FUNCTIONAL CHECK WITH 424 HRS OF OPERATION LOGGED. FOLLOWING INVESTIGATION IT WAS FELT THIS OCCURRENCE WAS RELATED TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS-ELEMA VENTILATOR VENTILATOR CBK ELECTRO MEDICAL GROUP SIEMENS MEDICAL SYSTEMS, INC. 900C *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention