BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUNO OTN, SFC EC

    MDR report key: 8232487 · Received January 9, 2019

    Report

    Report Number
    8010652-2019-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 13, 2018
    Report Date
    March 12, 2019
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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). THE MALFUNCTION COULD BE TRACED BACK TO THE TABLES CONTROL BOARD. THE AFFECTED BOARD WAS RETURNED FOR FURTHER INVESTIGATION. THIS INVESTIGATION REVEALED THAT A SHORT CIRCUIT ON ONE CAPACITOR HAD CAUSED THE ISSUE. THE AFFECTED BOARD WAS MANUFACTURED IN 2013. THE CUSTOMER CONFIRMED IT WAS ON STOCK FOR FOUR YEARS AND MOUNTED TO THE AFFECTED TABLE IN AUGUST 2017. IT CANNOT BE DETERMINED WHAT EXACTLY CAUSED THE MENTIONED SHORT CIRCUIT. THIS MIGHT BE DUE TO A MISTAKE AT THE SUPPLIERS' OR SUBSUPPLIERS' SIDE. THE AFFECTED CAPACITOR COULD HAVE BEEN DELIVERED FAULTY, YET FUNCTIONAL OR COULD HAVE BEEN DAMAGED WHEN MOUNTED TO THE BOARD (SUPPLIER). ANOTHER ROOT CAUSE FOR THIS ISSUE COULD BE RELATED TO ELECTROMAGNETIC COMPATIBILITY (EMC). OTHER DEVICES IN THE ROOM MIGHT CAUSE A CURRENT IN THE CABLES OF THE REMOTE CONTROL. THIS CURRENT COULD DAMAGE THE CAPACITOR. 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. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE INVESTIGATION IS STILL ONGOING.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE SURGERY, WHEN THE PATIENT WAS ON THE TABLE, THE OPERATING TABLE WAS NOT FUNCTIONING. THE START OF THE PROCEDURE WAS DELAYED. THE SURGERY WAS PERFORMED AND FINISHED ON THE AFFECTED TABLE. NO INJURY HAS BEEN REPORTED. MFR REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25201 YUNO OTN, SFC EC TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 143301BO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other