BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLE, OPERATING-ROOM, AC-POWERED

    MDR report key: 7898130 · Received September 21, 2018

    Report

    Report Number
    8010652-2018-00022
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 22, 2018
    Report Date
    October 11, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE EXEMPTION # E2018005. (B)(4), CONTACT PERSON: (B)(6). THE PRODUCT IN QUESTION IS STILL IN USE AT THE CLINIC. WE HAVE BEEN ABLE TO REPRODUCE THE BEHAVIOR DESCRIBED BY THE CUSTOMER WITH AN IDENTICAL PRODUCT. IF ONLY ONE SENSOR DETECTS A TRANSPORTER, AS IS THE CASE CAUSED BY A STOOL, THEN AN ERROR MESSAGE IS ISSUED INDICATING THAT THE TRANSPORTER IS NOT IN THE CORRECT POSITION. (INCORRECT TRANSPORTER POSITION). THE PROCEDURE / ADJUSTMENT OF THE SYSTEM IS NOT POSSIBLE IN THIS CASE. THIS BEHAVIOR IS INTENDED BECAUSE THERE IS A RISK OF DAMAGE WHEN USING A TRANSPORTER AND MOVING THE SYSTEM AT THE SAME TIME. THE TABLE CAN ONLY BE TRANSFERRED TO THE TRANSPORTER IN CERTAIN CONDITIONS. TO TRIGGER THE SENSOR FOR THE TRANSPORTER DETECTION, A METALLIC OBJECT MUST BE PLACED DIRECTLY IN FRONT OF THE SENSOR. IF ONLY ONE SENSOR IS ACTIVATED, AN ERROR MESSAGE WILL SHOW UP AS DESCRIBED ABOVE. THE ERROR MESSAGE IS ACCOMPANIED BY AN ACOUSTIC SIGNAL. IF THE METALLIC OBJECT IS REMOVED FROM THE SENSOR THE SYSTEM IS FULLY FUNCTIONAL AGAIN. NO FURTHER ACTIONS ARE PLANNED SINCE THERE WAS NO PRODUCT FAILURE AND THIS IS THE FIRST AND ONLY CASE SUCH ISSUE WAS REPORTED TO GETINGE-MAQUET.

    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 FDA. 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).

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE # (B)(4).

    Description of Event or Problem · 0

    DURING AN ONGOING SURGERY IT WAS REQUIRED TO POSITION THE PATIENT IN TRENDELENBURG POSITION, HOWEVER THE COLUMN WAS NOT RESPONDING TO THE HAND CONTROL. NO INJURY HAS BEEN REPORTED. MEDICAL INTERVENTION WAS NEEDED AS THE PATIENT'S BLOOD PRESSURE NEEDED TO BE CORRECTED WITH INTRAVENOUS TREATMENT WITH MORE PHARMACEUTICAL TREATMENT THAN NECESSARY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739797 TABLE, OPERATING-ROOM, AC-POWERED TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 118001A0

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention