BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO VENTILATOR 900C

    MDR report key: 39719 · Received September 26, 1996

    Report

    Report Number
    8010042-1996-00015
    Event Type
    Injury
    Date Received
    September 26, 1996
    Date of Event
    September 6, 1996
    Report Date
    September 26, 1996
    Manufacturer
    SIEMENS-ELEMA AB
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM COULD NOT BE VERIFIED, AND OPERATING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE VENTILATOR WAS CONNECTED TO A PT. THE CUSTOMER REPORTS THAT THE INSPIRATORY PRESSURE ROSE AND WAS HELD AT 60CM H20. THE EXPIRED MIN VOL ALARM ACTIVATED. THE PT'S BLOOD PRESSURE FELL UNTIL THE DR REMOVED THE INSPIRATORY PT TUBE FROM THE VENTILATOR. THE PT'S BLOOD PRESSURE STABILIZED. THE VENTILATOR WAS THEN SWITCHED BACK TO THE ORIGINAL MODE OF VENTILATION AND THE VENTILATOR OPERATED NORMALLY. THE CUSTOMER THEN PROCEDED TO USE THE VENTILATOR FOR THE NEXT CASE WITH NO PROBLEMS. THERE WAS NO PT INJURY. INTERNAL # V96117.

    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 UNKNOWN Required Intervention