BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPUS

    MDR report key: 373393 · Received January 18, 2002

    Report

    Report Number
    9611388-2001-00007
    Event Type
    Malfunction
    Date Received
    January 18, 2002
    Date of Event
    November 13, 2001
    Report Date
    January 8, 2002
    Manufacturer
    DORNIER MEDIZINTECHNIK GMBHH
    Product Code
    KQS
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AFTER ACTIVATION OF Z-AXIS BY FOOTSWITCH, K-AXIS MOVED AUTONOMOUSLY INSPITE OF ACTIVATION OF MOVEMENT STOP. NO PATIENT WAS INVOLVED. DESTRUCTION OF CLINICAL EQUIPMENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPUS X-RAY TABLE KQS DORNIER MEDIZINTECHNIK GMBHH OPUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *