BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900 VENTILATOR

    MDR report key: 353048 · Received September 21, 2001

    Report

    Report Number
    2112667-2001-00075
    Event Type
    Malfunction
    Date Received
    September 21, 2001
    Report Date
    September 19, 2001
    Manufacturer
    DATEX-OHMEDA
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT, DURING A CASE, THE VENTILATOR SCREEN BLANKED OUT. THERE WAS NO REPORTED PT INJURY. INVESTIGATION/CONCLUSION: THE EL DISPLAY WAS RETURNED TO THE MFG SITE FOR INVESTIGATION. THE PART WAS TESTED, AND THE REPORTED COMPLAINT WAS CONFIRMED. IT WAS DETERMINED THAT THE FAILURE OF Q312 FET CAUSED THE REPORTED COMPLAINT. AN ENGINEERING CHANGE HAS SINCE BEEN MADE TO REPLACE COMPONENT BSP 92 FET WITH BSP 225 FET TO HELP PREVENT A RECURRENCE. DURING THE REPORTED EVENT, THE VENTILATOR CONTINUED TO OPERATE WITH AUDIBLE ALARMS AND VISIBLE MOVEMENT OF THE BELLOWS. THE USER ALWAYS HAS THE OPTION OF SWITCHING TO MANUAL VENTILATION IF THE VENTILATOR PERFORMANCE IS IN QUESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43193 7900 VENTILATOR ANESTHESIA VENTILATOR CBK DATEX-OHMEDA 7900 VENTILATOR NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN