BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLE, OPERATING ROOM, AC POWERED

    MDR report key: 8180799 · Received December 19, 2018

    Report

    Report Number
    8010652-2018-00029
    Event Type
    Malfunction
    Date Received
    December 19, 2018
    Date of Event
    November 17, 2018
    Report Date
    July 16, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THIS REPORT THE INVESTIGATION WAS STILL ONGOING. AS SOON AS THE INVESTIGATION IS FINISHED THE REPORT WILL BE UPDATED AND A FOLLOW-UP/FINAL REPORT WILL BE PROVIDED TO THE FDA. 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).

    Additional Manufacturer Narrative · 0

    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 A MICRO SWITCH INDICATING A TILT OF THE TABLE OF MORE THAN 2° IS ACTIVATED, THE TABLES MOVEMENTS ARE LOCKED. THIS IS DONE TO PREVENT THE TILTING OF A TABLE SET ON THE CASTORS, SINCE THIS SITUATION WOULD POSE A RISK FOR THE PATIENT. WE ASSUME THAT A USE ERROR HAS CAUSED THE DESCRIBED MALFUNCTION. THE CUSTOMER HAS NOT ACTUATED THE PEDAL LONG ENOUGH AND THIS HAS CAUSED SOME PRESSURE WITHIN THE MENTIONED SYSTEM. THE CUSTOMER REPORTED THAT TABLE WAS SET INTO A TRENDELENBURG POSITION AND TILTED. WE ASSUME THAT THIS HAS CAUSED THE CENTER OF GRAVITY TO SHIFT AND THE PRESSURE WITHIN THE SYSTEM TO INCLINE. THIS HAS CAUSED THE PRESSURE SWITCH TO BE ACTIVATED. SINCE THE PRESSURE SWITCH WAS ACTIVATED AND THE MICROSWITCH FOR TILT WAS ACTIVATED, THE TABLES FUNCTIONS WERE BLOCKED. 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 BY THE CUSTOMER THAT DURING AN ONGOING SURGERY, THE OPERATING TABLE COULD NOT BE OPERATED ANYMORE. THE SURGERY WAS FINISHED IN AN UNSUITABLE POSITION. THE PATIENT NEEDED TO THE TRANSFERRED TO HIS BED FOR WAKE UP AND NEEDED AN EXTRA DOSE OF MEDICATION. THE WAKE UP WAS REPORTED TO BE SLIGHTLY DELAYED. NO INJURY HAS BEEN REPORTED. (B)(4).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER: 2018-61551.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017372 TABLE, OPERATING ROOM, AC POWERED TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 118001D0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other