BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR UNIVERSAL TABLE TOP

    MDR report key: 7832169 · Received August 30, 2018

    Report

    Report Number
    8010652-2018-00015
    Event Type
    Malfunction
    Date Received
    August 30, 2018
    Date of Event
    July 4, 2018
    Report Date
    February 15, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). FURTHER INFORMATION WAS REQUESTED FROM THE CUSTOMER BUT AT THE TIME OF THIS REPORT NOTHING WAS AVAILABLE. AS SOON AS INFORMATION IS AVAILABLE THE INVESTIGATION WILL BE UPDATED AND A FOLLOW-UP REPORT WILL BE SUBMITTED. THE BIOMEDICAL ENGINEER FROM THE CLINIC CHANGED THE GREEN SEALS AT THE JOINTS OF THE TABLE IN ORDER TO OPTIMIZE THE TIGHTENING OF THE LOCK.

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET GMBH (B)(4). EXEMPTION # E2018004. (B)(4), CONTACT PERSON: (B)(6). THE AFFECTED PRODUCT WAS MANUFACTURED I N 2008. THE FOLLOWING MALFUNCTION WAS REPORTED: THE ATTACHED HEAD PLATE WENT DOWN DURING SURGICAL INTERVENTION. THE HEAD PLATE IS LOCKED AT THE TABLE INTERFACE VIA TWO TOOTHED DISCS WHICH ARE PRELOADED VIA RUBBER BUFFERS. THE CUSTOMER DECIDED TO LET THE PRODUCT BE REPAIRED BY A THIRD PARTY TECHNICIAN. ALL TOOTHED DISCS AND RUBBER BUFFERS HAVE BEEN REPLACED. THE DESCRIBED ISSUE COULD BE CAUSED BY WORN OUT TOOTH DISCS AND /OR RUBBER BUFFERS , OR THE CONNECTION WAS NOT SECURED PROPERLY BY THE USER, OR THE CONNECTION WAS LOOSENED UNNOTICED DURING THE PROCEDURE, OR THE CONNECTION GAVE WAY DUE TO OVERLOAD, OR AN UNFORTUNATE COMBINATION OF THE DESCRIBED SITUATIONS. IN THE INSTRUCTIONS FOR USE (IFU) IT IS STATED THAT GETINGE-MAQUET PRODUCTS MAY BE USED ONLY WHEN FULLY FUNCTIONAL. FURTHER IT IS STATED THAT DEVICES HAVE TO BE CHECKED/ INSPECTED FOR FUNCTIONAL AND MECHANICAL INTEGRITY BEFORE UTILIZATION. BESIDES IT WAS STATED IN THE IFU THAT IN ORDER TO ENSURE THE OPERATIONAL SAFETY OF THE PRODUCT, AN INSPECTION MUST BE CARRIED OUT ANNUALLY IN ACCORDANCE WITH THE GENERALLY RECOGNIZED RULES OF TECHNOLOGY. THE INSPECTION INCLUDES TECHNICAL SAFETY CHECKS AS WELL AS ANY LUBRICATION OF THE PRODUCT. THE INSPECTION IS TO CARRIED OUT BY SPECIALIZED PERSONNEL WHO, ON ACCOUNT OF THEIR EDUCATION, KNOWLEDGE AND EXPERIENCE GAINED FROM PRACTICAL ACTIVITIES, ARE CAPABLE OF CORRECTLY EXECUTING THE TECHNICAL SAFETY CHECKS. N INSPECTION WAS REQUESTED FROM OR PERFORMED BY GETINGE TECHNICIANS SINCE COMMISSIONING. ADDITIONALLY THE ALLOWED LOADS FOR THIS PRODUCT ARE PROVIDED IN THE IFU AS WELL AS A DETAILED DESCRIPTION ON HOW TO SECURE THE CONNECTION. GETINGE-MAQUET PROVIDES THE FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    DURING A PROCEDURE THE EXTENSION ELEMENT ON THE HEAD SIDE BROKE. THE PATIENT FELL FORWARD BUT WAS CAUGHT BY THE CLINICAL STAFF. THE PLANNED INTERVENTION WAS NOT FULLY REALIZED. NO INJURY WAS REPORTED TO GETINGE-MAQUET. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672769 MODULAR UNIVERSAL TABLE TOP TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 115030BO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention