BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET OPERATING TABLE SYSTEM TRANSPORTER

    MDR report key: 2223499 · Received June 14, 2011

    Report

    Report Number
    8010652-2011-00002
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 17, 2011
    Manufacturer
    MAQUET GMBH & CO. KG
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET SERVICE HAS REPLACED THE BROKEN SCREW AND RETURNED THE TROLLEY TO SERVICE. PRESENTLY, THE ROOT CAUSE FOR THIS INCIDENT IS UNK. MAQUET HAS REQUESTED THE BROKEN SCREW TO BE RETURNED FOR FURTHER ANALYSIS. MAQUET HAS BEEN ABLE TO SIMULATE THE BREAKAGE OF THE RETAINING SCREW REPORTED (WITH THE TROLLEY SUPPORTING A TABLETOP WITH A LOAD OF 180KG) BY REMOVING THE SCREW. HOWEVER, IN TEST, THE TABLETOP NEVER FELL TO THE FLOOR. BECAUSE THE CARRIER FRAME IS FIXED ON THREE POINTS: A LEFT AND RIGHT ROTATION JOINT FOR TRENDELENBURG (ONLY ONE OF THEM WAS BROKEN) AND THE TRENDELENBURG /REVERSE TRENDELENBURG CYLINDER. EVEN IF ONE SCREW FAILED, THE REMAINING JOINTS WOULD HAVE BEEN SUFFICIENT TO SUPPORT THE TABLETOP. GIVEN WHAT IS KNOWN, MAQUET SUSPECTS CUSTOMER MISUSE AS THE ROOT CAUSE OF THE ISSUE. NO SIMILAR INCIDENT WITH THIS TRANSPORTER HAS BEEN REPORTED TO MAQUET SINCE THE LAUNCH OF THIS PRODUCT. (B)(4). SHOULD ADD'L DETAILS BECOME AVAILABLE, A F/U MDR WILL BE SUBMITTED. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE CUSTOMER, THE FIXATION SCREW BROKE DURING TRANSFER OF THE PT FROM THE TABLE TOP TO HOSPITAL BED. THE TABLE TOP FELL DOWN ON FOOT SIDE. NO INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET OPERATING TABLE SYSTEM TRANSPORTER STRETCHER, WHEELED; CODE: FPO FPO MAQUET GMBH & CO. KG 1140.62C0

    Patients

    Seq Age Sex Outcome Treatment
    1