BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPERON B810

    MDR report key: 512794 · Received January 13, 2004

    Report

    Report Number
    1220685-2003-00006
    Event Type
    Other
    Date Received
    January 13, 2004
    Date of Event
    December 15, 2003
    Report Date
    December 22, 2003
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CASE WITH A PT POSITIONED ON A B810 SURGICAL TABLE, THE PRIMARY HAND PENDANT FAILED. REPORTEDLY, ANY BUTTON PRESSED RESULTED IN THE DOWNWARD MOVEMENT OF THE BACK SECTION. THE SECTIONS MOVE SLOWLY SO THE HOSP PERSONNEL REPEATEDLY TRIED TO OPERATE THE PRIMARY HAND PENDANT AFTER THE INITIAL MALFUNCTION WHICH RESULTED IN THE BACK SECTION BEING LOWERED TO A POINT THAT COULD HAVE COMPROMISED THE PT'S SAFETY. THE LABELING STATES THAT IF THE PRIMARY HAND PENDANT FAILS THEN THE AUXILLARY PENDANT SHOULD BE UTILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERON B810 SURGICAL TABLE FQO BERCHTOLD CORP. B810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other