BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMEDA SURGICAL FREE FLOW VACUUM REGULATOR

    MDR report key: 484508 · Received September 19, 2003

    Report

    Report Number
    1121732-2003-00004
    Event Type
    Injury
    Date Received
    September 19, 2003
    Date of Event
    July 9, 2003
    Report Date
    August 14, 2003
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    KDP
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE OHMEDA MEDICAL VACUUM REGULATOR INVOLVED IN THIS REPORT WAS BEING USED AS A COMPONENT OF A HEART STABILIZATION DEVICE MARKETED BY ANOTHER COMPANY AND USED DURING BEATING HEART SURGERY. IT WAS REPORTED THAT A HEART TISSUE INJURY OCCURRED IN THE PROXIMITY OF THE SUCTION APPLICATOR. THE INJURY WAS SURGICALLY REPAIRED AND THE PATIENT HAS SINCE RECOVERED. IT WAS ALSO REPORTED THAT, AT THE TIME OF THE INJURY, THE VACUUM LEVEL PROVIDED BY THE OHMEDA MEDICAL DEVICE INCREASED AFTER AN ACCIDENTAL IMPACT ON THE IV POLE ON WHICH THE DEVICE WAS MOUNTED. OHMEDA MEDICAL OBTAINED THE SUBJECT DEVICE, MANUFACTURED IN 1999, AND WAS ABLE TO CONFIRM THAT THE VACUUM LEVEL COULD BE CHANGED BY IMPACT. INSPECTION OF THE DEVICE REVEALED THAT THE CONTROL KNOB TORQUE WAS NOT SET TO MANFACTURING SPECIFICATIONS OR SERVICE RECOMMENDATIONS, AND THIS CONTRIBUTED TO THE UNINTENDED ROTATION OF THE KNOB UNDER IMPACT CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA SURGICAL FREE FLOW VACUUM REGULATOR SUCTION REGULATOR KDP OHMEDA MEDICAL 6710-1247-928 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention MEDTRONIC URCHIN HEART POSITIONER.