BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUS OP TABLE COLUMN - SURFACE MOUNTED

    MDR report key: 8304514 · Received February 5, 2019

    Report

    Report Number
    8010652-2019-00003
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    November 30, 2018
    Report Date
    February 5, 2019
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE AFFECTED DEVICE WAS INVESTIGATED BY A GETINGE -MAQUET SERVICE TECHNICIAN. HE FOUND THAT SOME SENSORS WERE SLIGHTLY MISADJUSTED. THE USER IS ADVISED IN THE INSTRUCTIONS FOR USE THAT AN INSPECTION HAS TO BE PERFORMED BY AN EXPERT ON AN ANNUAL BASIS TO ENSURE SAFE OPERATION OF THE PRODUCT. WITHIN THIS INSPECTION THE SENSORS ARE CHECKED AND READJUSTED IF REQUIRED. BESIDES THE SERVICE TECHNICIAN RECOGNIZED THAT THE TRANSFER CART (GE EQUIPMENT) WAS NOT FULLY LEVEL. HE ADJUSTED THE TABLE TO MAKE UP FOR THIS SLIGHT MISALIGNMENT. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    THE PATIENT WAS TRANSFERRED WITH THE TRANSFER BOARD FROM THE OPERATING ROOM TABLE (GETINGE -MAQUET PRODUCT) TO EQUIPMENT FROM GENERAL ELECTRICS(GE) . THIS WAS DONE TO PERFORM INTRA-OPERATIVE MR IMAGING. THE CUSTOMER FACED DIFFICULTIES WHEN TRANSFERRING THE USED TRANSFER BOARD BACK FROM GE EQUIPMENT TO THE OPERATING ROOM TABLE COLUMN (GETINGE-MAQUET PRODUCT). AS A RESULT THE SURGERY WAS DELAYED BY APPROXIMATELY 90 MINUTES. IT WAS FINISHED ON THE GE EQUIPMENT. THERE WAS NO REPORT THAT THE OUTCOME OF THE PROCEDURE WAS NEGATIVELY AFFECTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101680 MAGNUS OP TABLE COLUMN - SURFACE MOUNTED TABLE, OPERATING-ROOM, AC-POWERED FQO 118001B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other