BEUDAMED
    FDA Adverse Event Death Summary report: N

    SERVO VENTILATOR 900C

    MDR report key: 145838 · Received January 22, 1998

    Report

    Report Number
    145838
    Event Type
    Death
    Date Received
    January 22, 1998
    Date of Event
    January 12, 1998
    Report Date
    January 21, 1998
    Manufacturer
    SIEMENS MEDICAL SYSTEMS, INC/ELECTROMEDICAL GROUP
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT POST OPERATIVE ABDOMINAL AORTIC ANEURYSM REPAIR; ON VENTILATORY SUPPORT. SYSTEM CHECK PRIOR TO PT USE REVEALED SETTINGS ACCURATE, CONSISTENT AND FUNCTIONING PROPERLY. PT PLACED ON VENTILATOR POST OP. ROUTINE CHECK OF VENTILATOR AT 1330 INDICATED NO MALFUNCTION. PT DEVELOPED HYPOTENSION. AT 1425 MALFUNCTION NOTED, I.E., PEEP SETTING AT 5CMH20, DELIVERING 20CMH20 (ACCORDING TO MANOMETER). REVIEW INDICATES MALFUNCTION WAS PROXIMATE CAUSE OF EPISODE OF HYPOTENSION WHICH, IN ASSOCIATION WITH PT'S PRE-EXISTING VASCUALR DISEASE, MAY HAVE CONTRIBUTED TO FAILURE IN LOWER EXTREMITY PERFUSION LEADING ULTIMATELY TO DEATH. VENTILATOR TO CLINICAL ENGINEERING. SYSTEM TESTED WITH AND WITHOUT PEEP. UNABLE TO ZERO EXPIRATORY PRESSURE TRANSDUCER. TRANSDUCER REPLACED, SYSTEM FUNCTIONED ACCURATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO VENTILATOR 900C VENTILATOR CBK SIEMENS MEDICAL SYSTEMS, INC/ELECTROMEDICAL GROUP SV900C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death