BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO VENTILATOR

    MDR report key: 35190 · Received August 12, 1996

    Report

    Report Number
    MW1009699
    Event Type
    Injury
    Date Received
    August 12, 1996
    Date of Event
    June 17, 1996
    Report Date
    July 31, 1996
    Manufacturer
    SIEMENS MEDICAL SYSTEMS,INC. ELECTROMEDICAL GROUP
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT EXPERIENCED HYPERTENSIVE/TACHYCARDIC EPISODE. THE VENTILATOR WAS DELIVERING PRESET BREATHS VOLUME. RT DID NOT THINK IMV BREATHS WERE CONSISTENT WITH PTS EFFORTS. BIOMED ENGINEER TESTED DEVICE AND FOUND TRIGGER SENSITIVITY TO BE INACCURATE AT A MEASURE OF >10CC H2O DUE TO A DEFECTIVE PRINTED CIRCUIT BOARD. THIS WAS REPLACED BY BIOMED. THE EVENT COULD HAVE BEEN SERIOUS IF THE RESPIRATORY THERAPIST WAS NOT PRESENT AS THE DEVICE FAILED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention