BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLE, OPERATING-ROOM, ELECTRICAL

    MDR report key: 6910954 · Received October 3, 2017

    Report

    Report Number
    6910954
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    June 8, 2017
    Report Date
    August 4, 2017
    Manufacturer
    SKYTRON, LLC
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OPERATING ROOM TABLE WAS PUT INTO STEEP TRENDELENBURG POSITION, CAUSING SAFETY BRACKETS ON BED TO DISENGAGE PART OF THE TABLE. PATIENT SLID TOWARD ANESTHESIA ABOUT 4-5 INCHES, WAS IMMEDIATELY NOTICED AND CAUGHT/SUPPORTED BY OPERATING ROOM STAFF AND SAFELY REPOSITIONED ON BED. NO INJURY WAS NOTED AT THIS TIME. CASE WAS CONVERTED TO OPEN DUE TO INABILITY TO POSITION PATIENT SAFELY IN TRENDELENBURG. PATIENT WAS REPREPPED, REDRAPED, AND CASE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692054 TABLE, OPERATING-ROOM, ELECTRICAL FQO SKYTRON, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR