BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEERA US WITHOUT AUTO DRIVE

    MDR report key: 7877379 · Received September 14, 2018

    Report

    Report Number
    8010652-2018-00019
    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 BE IDENTIFIED. THE POWER CONNECTION WAS PHYSICALLY DAMAGED. WITH A DAMAGED POWER CONNECTION THE OPERATING TABLE CANNOT BE CHARGED ANYMORE AND WHEN THE BATTERY IS FULLY DISCHARGED THE TABLE STOPS WORKING. BEFORE THE OPERATING TABLE STOPS WORKING ACOUSTICAL AND VISIBLE ALARMS SIGNALIZE THAT THE BATTERIES NEED TO BE CHARGED / THAT THE OPERATING TABLE NEED TO BE CONNECTED TO THE MAINS POWER. THE CUSTOMER HAS TIME TO REACT AND IN THIS CASE THE DEFECTIVE POWER CONNECTION COULD HAVE BEEN IDENTIFIED BEFORE THE TABLE STOPPED COMPLETELY. THE DEFECTIVE POWER CONNECTION MAINS ASSEMBLY WAS EXCHANGED AND PROPER OPERATION OF THE TABLE VERIFIED. GETINGE - MAQUET WAS INFORMED BY THE FDA ON 2018-08-20 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

    OPERATING TABLE STOPPED WORKING (NO PATIENT ON IT). LOCKOUT TAG SHOWED THE PROBLEM AS: BED POWER CORD BROKEN. MANUFACTURER REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716661 MEERA US WITHOUT AUTO DRIVE TABLE, OPERATING-ROOM, AC-POWERED FQO HOLGER ULLRICH 720001F0

    Patients

    Seq Age Sex Outcome Treatment
    1