BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE/CASTLE

    MDR report key: 1649416 · Received April 1, 2010

    Report

    Report Number
    1225700-2010-00055
    Event Type
    Malfunction
    Date Received
    April 1, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 2, 2010
    Manufacturer
    MAQUET, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON ARRIVAL AT THE HOSP, THE MAQUET INC FIELD SERVICE TECH (FST) FOUND THE TABLE INOPERABLE. THE FST TRACED THE PROBLEM TO THE TABLE'S LOW VOLTAGE CONTROL BOX. THIS COMPONENT HAD COMPLETELY FAILED. THIS PART CONTROLS ALL TABLE MOVEMENT AND COULD HAVE CONTRIBUTED TO THE INCIDENT DESCRIBED BY THE CUSTOMER. HOWEVER, THE FST COULD NOT IMPLEMENT THE REPAIRS REQUIRED TO VERIFY THIS, AS LOW VOLTAGE CONTROL BOX IS NO LONGER AVAILABLE. MAQUET INC HAS DEPLETED THIS PART FROM ITS INVENTORY OF DISCONTINUED SHAMPAINE TABLE COMPONENTS. MAQUET INC HAS INFORMED THE CUSTOMER THAT THEY CANNOT RETURN THIS TABLE TO SERVICE. THE TABLE INVOLVED IN THIS INCIDENT WAS MANUFACTURED BY GETINGE/CASTLE IN 1998. MFG OF THESE TABLES HAS SINCE STOPPED. THE MFG SITE IN (B)(4) IS NOW CLOSED. PRODUCT COMPLAINTS FOR (B)(4) PRODUCTS WILL CONTINUES TO BE PROCESSED BY THE MAQUET INC (GETINGE GROUP) SALES AND SERVICE UNIT (FIRST IMPORTER) IN (B)(4).

    Description of Event or Problem · 1

    DURING AN UNIDENTIFIED PROCEDURE, THE MOTOR OF THE SURGICAL TABLE TURNED ON AND THE TABLE UNLOCKED ITSELF FROM THE FLOOR AND BEGAN TO MOVE. THE HOSPITAL STAFF WAS ABLE TO SECURE THE TABLE AND COMPLETE THE CASE. THERE WAS NO INJURY OR ADVERSE AFFECT TO THE PT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GETINGE/CASTLE FQO MAQUET, INC. 5100B

    Patients

    Seq Age Sex Outcome Treatment
    1