BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TABLE, OPERATING-ROOM, AC POWERED

    MDR report key: 7538586 · Received May 23, 2018

    Report

    Report Number
    8010652-2018-00009
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    April 25, 2018
    Report Date
    May 23, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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). GETINGE-MAQUET WAS INFORMED OF THE ISSUE BY THE CLINIC. THE FOOT WAS INJURED AND THE FOOT NEEDED SOME MEDICAL TREATMENT AFTER THE PROCEDURE WAS FINISHED. THERE WERE NO BROKEN BONES. NO PERMANENT DAMAGE WAS REPORTED TO GETINGE-MAQUET. THERE WAS NO DELAY IN THE PROCEDURE DUE TO THIS ISSUE. THE CLINIC ADMITTED THAT THE ISSUE TOOK PLACE DUE TO OPERATOR ERROR BY THE USER. THE INCIDENT WAS CAUSED BY USER ERROR. IN THE INSTRUCTION FOR USE (IFU) IT IS STATED THAT THE USER HAS TO PAY ATTENTION AND REMOVE POTENTIAL HINDRANCE PRIOR TO MOVING / ADJUSTING THE MOBILE OPERATING ROOM TABLE AND AVOID COLLISIONS. THERE WAS NO MALFUNCTION OF THE MAQUET DEVICE. THE INJURY WAS CAUSED BY USER ERROR. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT A MEDICAL STAFF INJURED HIS FOOT DURING THE USE OF THE OPERATING TABLE. THEY REPORTED THEY PLACED A BUCKET UNDER THE TALE. WHEN ADJUSTING THE TABLE THE LEG PLATE COLLIDED WITH THE BUCKET AND THE TABLE BASE WAS LIFTED. THIS WAS NOT NOTICED BY THE CLINIC STAFF. ONE CLINIC STAFF PLACED HIS FOOT UNDER THE TABLE BASE . WHEN READJUSTING THE TABLE, THE TABLE BASE DROPPED ON THE FOOT OF THE CLINIC STAFF. THE CLINIC STAFF FOOT WAS INJURED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381316 TABLE, OPERATING-ROOM, AC POWERED TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 113222BO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other