BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHAMPAINE

    MDR report key: 1591198 · Received January 27, 2010

    Report

    Report Number
    1225700-2010-00012
    Event Type
    Other
    Date Received
    January 27, 2010
    Date of Event
    December 1, 2009
    Report Date
    December 28, 2009
    Manufacturer
    MAQUET, INC.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC SERVICE CHECKED THE TABLE FOR ANY MECHANICAL ISSUES (E.G. BAD CHECK VALUES, HYDRAULIC LEAKS, CONTROLLER BOX FAILURE, ETC.) NONE COULD BE FOUND. THE SERVICE TECHNICIANS MADE MULTIPLE ATTEMPTS TO REPRODUCE THE FAILURE BUT COULD NOT DO SO. HOSPITAL STAFF COULD NOT CONCLUSIVELY RULE OUT THE POSSIBILITY OF OPERATOR ERROR AT THE TIME OF THE EVENT. THE TABLE WAS UNDER A MAQUET INC. SERVICE AGREEMENT PRIOR TO AND AT THE TIME OF THE INCIDENT WHICH WAS IDENTIFIED DURING THE FINAL SERVICE CALL. CURRENTLY, THE TABLE IS NOT UNDER A SERVICE AGREEMENT WITH MAQUET INC. A REVIEW OF THE SERVICE LOGS FOR THE PREVIOUS TWO YEARS FOUND NO REPORTS OF ANY MECHANICAL ISSUES CONSISTENT WITH THE ALLEGED MOVEMENT. THE TABLE INVOLVED IN THIS INCIDENT WAS MANUFACTURED BY (B)(4) IN 1995. MANUFACTURING OF THESE TABLES HAS SINCE STOPPED. CURRENTLY, THE MANUFACTURING SITE IN (B)(4) IS IN THE PROCESS OF BEING CLOSED DOWN AND THE PRODUCT COMPLAINTS FOR (B)(4) PRODUCT GOING FORWARD ARE BEING PROCESSED BY THE MAQUET INC. ((B)(4)) SALES AND SERVICE UNIT (FIRST IMPORTER) IN (B)(4).

    Description of Event or Problem · 1

    WHILE ON SITE FOR A SCHEDULED SERVICE VISIT, A HOSPITAL NURSE REPORTED THAT DURING AN EAR, NOSE AND THROAT PROCEDURE WHICH TOOK PLACE ON OR NEAR (B)(6) 2009, THERE WAS A SUDDEN MOVEMENT OF THE TABLE TOP TO EITHER THE LEFT OR RIGHT (EXACT DIRECTION OF THE MOVEMENT WAS UNK.). ALTHOUGH, THE PT'S TORSO WAS STRAPPED TO THE TABLE, THE MOVEMENT WAS SUFFICIENT TO CAUSE PT'S LEG TO SLIDE OFF TABLE TOP. NO INJURY RESULTED FROM THIS INCIDENT; THE TABLE WAS RESET, AND THE PROCEDURE WAS ABLE TO CONTINUE UNINTERRUPTED AFTER THE EVENT. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1