BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO VENTILATOR 900C

    MDR report key: 39970 · Received September 9, 1996

    Report

    Report Number
    8010042-1996-00010
    Event Type
    Malfunction
    Date Received
    September 9, 1996
    Date of Event
    August 9, 1996
    Report Date
    September 9, 1996
    Manufacturer
    SIEMENS-ELEMA AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM COULD HAVE BEEN CAUSED BY A COMBINATION OF A RESTRICTED THROAT (AS REPORTED BY THE HOSPITAL) AND/OR SOFT TUBING.

    Description of Event or Problem · 1

    THE HIGHEST TIDAL VOLUME THE VENTILATOR WOULD DELIVER WAS 600ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO VENTILATOR 900C VENTILATOR CBK SIEMENS-ELEMA AB SV900C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention