BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEERA EU WITHOUT AUTO DRIVE

    MDR report key: 8361534 · Received February 22, 2019

    Report

    Report Number
    8010652-2019-00008
    Event Type
    Malfunction
    Date Received
    February 22, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 22, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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 GMBH, KEHLER STRASSE 31, RASTATT, GERMANY 76437. EXEMPTION # E2018004. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE FAILURE DESCRIBED BY THE CUSTOMER COULD BE REPRODUCED AT MAQUET. A SUPPLIER COMPLAINT REVEALED A PROBLEM WITH THE OFFSET OF THE PLASTIC SOCKET. IT MAY BE POSSIBLE THAT IN SOME CASES THE PLASTIC SOCKET IS NOT PRESSED DEEP ENOUGH INTO THE HOUSING SO THAT NOT BOTH PINS SECURE THE PLASTIC SOCKET IN THE HOUSING. FURTHER TESTS BY THE SUPPLIER SHOWED THAT WHEN JUST ONE PIN IS FIXED THE CONNECTION MEETS ITS SPECIFICATION. IN THE INSTRUCTIONS FOR USE (IFU) THE CONNECTION TO MAINS SUPPLY AND THE DETACHMENT OF THE MAINS CABLE IS DESCRIBED. FOR DETACHING IT IS STATED: ¿DETACH THE PLUG AT THE MAIN SOCKET. DETACH THE MAINS CABLE FROM THE MOBILE OPERATING TABLE.¿ THIS MEANS THE CUSTOMER FIRST HAS TO DISCONNECT THE CABLE FROM THE MAINS SOCKED (FROM THE WALL) AND THEN PULL THE PLUG OUT OF THE TABLE. JUST A COMBINATION OF NOT CORRECT ASSEMBLED COLD-DEVICE-PLUG AND NOT FOLLOWING THE IFU CAN LEAD TO THE DESCRIBED FAILURE. THE AFFECTED TABLE WAS REPAIRED BY GETINGE SERVICE TECHNICIAN. GETINGE-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 AT LEAST TWO PEOPLE RECEIVED AN ELECTRIC SHOCK BY TOUCHING A PULLED OUT SOCKET. A SOCKET WAS PULLED OUT OF THE TABLE WHEN THE USER TRIED TO DISCONNECT THE MAINS CABLE FROM THE OPERATING ROOM TABLE. THE MAINS CABLE WAS PLUGGED IN AT THE MAINS SOCKET IN THE WALL. THE CUSTOMER TOLD US THAT THE NURSE TOUCHED TWO PEOPLE WITH THE CABLE. THESE RECEIVED AN ELECTRIC SHOCK. NO MEDICAL INTERVENTION OR SERIOUS INJURY WAS REPORTED. MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154285 MEERA EU WITHOUT AUTO DRIVE TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 720001B0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other