BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEERA US WITHOUT AUTO DRIVE

    MDR report key: 7877295 · Received September 14, 2018

    Report

    Report Number
    8010652-2018-00018
    Event Type
    Malfunction
    Date Received
    September 14, 2018
    Report Date
    September 14, 2018
    Manufacturer
    HOLGER ULLRICH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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). GETINGE - MAQUET SERVICE TECHNICIAN VISITED THE CLINIC AND INVESTIGATED THE PRODUCT IN QUESTION. THE DESCRIBED MALFUNCTION COULD NOT BE REPRODUCED. THE ONLY ISSUE DETECTED BY THE SERVICE TECHNICIAN WHEN INVESTIGATING THE TABLE IN QUESTION WAS PHYSICALLY DAMAGED COVERS OF THE TABLE COLUMN. ALL FUNCTIONS OF THE OPERATING TABLE WERE AVAILABLE. GETINGE - MAQUET WAS INFORMED BY THE FDA ON (B)(6) 2018 THAT THE CLINIC REPORTED THE ISSUE TO THE FDA. GETINGE - MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    PATIENT WAS ON THE TABLE ALREADY PUT TO SLEEP BY THE ANESTHESIOLOGIST WHEN THE OR TABLE STOPPED WORKING. LOCKOUT TAG SHOWED THE PROBLEM AS NO POWER SOURCE.MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716660 MEERA US WITHOUT AUTO DRIVE TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 720001F0

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR