BEUDAMED
    FDA Adverse Event Other Summary report: N

    SURGICAL FREE FLOW VACUUM REGULATOR

    MDR report key: 553742 · Received November 8, 2004

    Report

    Report Number
    1121732-2004-00018
    Event Type
    Other
    Date Received
    November 8, 2004
    Report Date
    November 8, 2004
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGICAL FREE FLOW VACUUM REGULATOR EXPLODED WHEN IT WAS ATTACHED TO THE WALL, SENDING DEBRIS INTO THE OPERATING ROOM. THE ON/OFF VALVE ON THE UNIT WAS IN THE 'ON' POSITION WHEN THE UNIT WAS ATTACHED TO THE WALL OUTLET, WHICH CAUSED WALL SUCTION THROUGH THE UNIT.NO PT OR STAFF INJURY WAS REPORTED. THE UNIT RECEIVED FROM THE FIELD WAS EVALUATED BY OHMEDA MEDICAL. IT APPEARS TO HAVE FAILED FROM EXCESSIVE FORCE CENTERED ON THE ADJUSTMENT KNOB IN AN OUTWARD DIRECTION. EVIDENCE SUGGEST THAT THIS WAS CAUSED BY A USER ERROR, I.E. AS OPPSED TO VACUUM, THE UNIT WAS SUBJECTED TO POSITIVE PRESSURE THAT RESULTED IN EXPANSION OF THE BELLOWS AND DAMAGE TO THE UNIT. THERE ARE APPROX. 30,000 UNITS IN THE FIELD WITH NO PREVIOUS HISTORY OF SIMILAR CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL FREE FLOW VACUUM REGULATOR VACUUM REGULATOR GCX OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other