BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX OHMEDA AEDSTIVA/5

    MDR report key: 1028491 · Received April 10, 2008

    Report

    Report Number
    MW5006228
    Event Type
    Malfunction
    Date Received
    April 10, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DATEX OHMED
    Product Code
    CAD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DATEX OHMEDA AESTIVA/5 ANESTHESIA MACHINE WITH PSVPRO VENTILATOR; VENTILATOR TURNED ON VT600 RATE 10. NOTICED AFTER APPROX 2 MINUTES THAT VENTILATION HAD NOT INITIATED. ON SCREEN VENTILATOR NOTIFICATION "INSPIRATORY FLOW SENSOR FAILURE" PATIENT'S O2 SAT REMAINED 100% -BRIEF PERIOD/APNEIC VENTILATION-. IN THE EVENT OF A MECHANICAL VENTILATOR FAILURE, THE VENTILATOR ALARM SHOULD ANNUNCIATE; IT DID NOT...REPLACED FLOW SENSOR MODULE; NORMAL FUNCTION RE-INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX OHMEDA AEDSTIVA/5 ANESTHESIA MACHINE/VENTILATOR CAD DATEX OHMED AESTIVA 7900CON

    Patients

    Seq Age Sex Outcome Treatment
    1 Other