BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGNUS OR-TABLE COOLUMN

    MDR report key: 7677504 · Received July 11, 2018

    Report

    Report Number
    8010652-2018-00010
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 11, 2018
    Report Date
    July 11, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF 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). INVESTIGATION IS ON-GOING. MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    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. (B)(4), CONTACT PERSON: (B)(6). THE CUSTOMER DESCRIBED THAT ERROR CODE 165/6 OCCURRED DURING THE SURGERY WHILE THE TABLE WAS IN A TILT POSITION. A GETINGE-MAQUET SERVICE TECHNICIAN VISITED THE CLINIC AND INVESTIGATED THE AFFECTED TABLE. THE ERROR THAT OCCURRED DURING THE SURGERY DID NOT SHOW UP AGAIN. THE ERROR COULD BE REPRODUCES ON THE SAME KIND OF TABLE MODEL. ERROR CODE 165/6 OCCURS IN CASE THE COLUMN IS TILTED AND A SWITCH INDICATING THE CASTOR POSITION IS ACTIVATED. IN THE INSTRUCTIONS FOR USE (IFU) IT IS DESCRIBED HOW THE CASTORS OF THE TABLE CAN BE RETRACTED TO LOCK THE TABLE. IF THE TABLE IS LOCKED, THIS IS REGISTERED BY A PRESSURE SWITCH. IN THE IFU IT IS DESCRIBED THAT A PEDAL NEEDS TO BE PUSHED UPWARDS FOR APPROXIMATELY 5 SECONDS TO RETRACT THE CASTORS AND LOCK THE TABLE. DURING THE REPRODUCTION, IT WAS FOUND THAT IN CASE THE PEDAL IS PUSHED UP NOT LONG ENOUGH, THE CASTORS ARE RETRACTED, BUT SOME PRESSURE IS LEFT IN THE HYDRAULIC SYSTEM FOR EXTRACTING THE CASTORS. SINCE THE HYDRAULIC SYSTEM IS NOT COMPLETELY PRESSURE FREE, A CHANGE OF THE CENTER OF GRAVITY (BY POSITIONING THE PATIENT) CAN LEAD TO A HIGHER PRESSURE IN THE HYDRAULIC SYSTEM. THIS CAUSES THE SWITCHING OF THE PRESSURE SWITCH. IF THE SWITCH IS CHANGED, A SIGNAL IS SENT TO THE CONTROLLER BOARD OF THE TABLE. IN CASE THIS SIGNAL IS RECEIVED AND THE TABLE IS TILTED MORE THAN 2°, ERROR CODE 165/5 IS DISPLAYED. THIS KIND OF MALFUNCTION HAS NEVER BEEN REPORTED BEFORE OR AFTERWARDS FOR THE AFFECTED TABLE. DUE TO THE DESCRIBED MALFUNCTION AND REPRODUCTION AT SITE, WE ASSUME THAT A USE ERROR HAS CAUSED THIS COMPLAINT. MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TABLE SYSTEM STOPPED WORKING DURING SURGERY. PROCEDURE FINISHED SUCCESSFULLY ON TABLE BUT WAS PROLONGED FOR APPROX. 40 MINUTES DUE TO THE ISSUE. (B)(4). NO INJURIES REPORTED TO GETINGE-MAQUET.

    Description of Event or Problem · 0

    MFG. REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522146 MAGNUS OR-TABLE COOLUMN TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 118001D0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other