BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET MAGNUS CARBON-FIBRE TABLE TOP

    MDR report key: 5998941 · Received October 4, 2016

    Report

    Report Number
    8010652-2016-00022
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Date of Event
    September 5, 2016
    Report Date
    September 5, 2016
    Manufacturer
    KEHLER STRASSE 31
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED DUE TO WRONG USE OF THE PRODUCT. THERE WAS NO PRODUCT FAILURE. THE CLINIC RECOGNIZED THE WRONG USAGE. THIS IS AN ISOLATED CASE. WE ARE NOT AWARE OF SIMILAR INCIDENTS WITH THIS TYPE OF DEVICE. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MAQUET, THAT DURING FLUOROSCOPY, THE TABLE 118016A1 (2500MM LONG) WAS USED WITH HEAD REST (200MM LONG), HOWEVER THESE ARE TOO SHORT TO FLUOROSCOPE PATIENT¿S LOWER EXTREMITY. ARM BOARD WAS USED BETWEEN THE HEAD REST AND THE MAT TO LENGTHEN TABLE. THE PATIENT WAS NOT BEING SECURED AND WAS UNSTABLE. IN A MOMENT, THE NURSE HELD THE PATIENT AND THE PATIENT WAS PROTECTED FROM EXTERNAL INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650369 MAQUET MAGNUS CARBON-FIBRE TABLE TOP TABLE, RADIOLOGIC KXJ KEHLER STRASSE 31 118016A1

    Patients

    Seq Age Sex Outcome Treatment
    1