BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET SA

    MDR report key: 1872663 · Received September 28, 2010

    Report

    Report Number
    9710055-2010-00012
    Event Type
    Other
    Date Received
    September 28, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K030906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH (FST) VISITED THE HOSPITAL TO INVESTIGATE THE CUSTOMER REPORT. THE FST FOUND THE LIGHT OUT OF SERVICE, IN THE HOSPITAL'S FACILITIES SHOP. THE FST FOUND THAT THE SNAP RING THAT SECURES THE LIGHT CEILING SUSPENSION TO THE CEILING TUBE WAS INSTALLED ON THE UNIT IN THE WRONG ORDER. ADDITIONALLY, THE FST NOTICED THAT THIS ASSEMBLY INCLUDED ONE EXTRA WASHER COMPARED TO THE MFR INSTRUCTIONS, AND THAT ONE TAB WASHER WAS BROKEN. IT IS BELIEVED THAT DUE TO THE INCORRECT ASSEMBLY AND DAMAGED TAB, THE SNAP RING COULD NOT BE CORRECTLY POSITIONED IN ITS GROOVE, AND THE ARM WAS ALLOWED TO SLIP DOWN AND FALL. THE AXL5001S INSTALLATION MANUAL CLEARLY INDICATES THAT A MISSING TAB WASHER MAY CAUSE THE SUSPENSION SYSTEM TO FALL DOWN. THE PREVENTIVE MAINTENANCE INSTRUCTIONS INCLUDE A VERIFICATION OF THIS ASSEMBLY. MAQUET IS NOT IN CHARGE OF MAINTENANCE OF LIGHTS IN THIS HOSPITAL. MAQUET DOES NOT KNOW IF THE HOSPITAL HAS RETURNED THE LIGHT TO SERVICE. THE HOSPITAL'S FACILITY MAINTENANCE CREW DECLINED MAQUET'S OFFER TO SERVICE THE LIGHTS AND INFORMED OUR FST THAT THEY WILL ORDERING THE REQUIRED PARTS AND CONDUCT THE REPAIR. MAQUET FST REPORTED THAT THE HOSPITAL STAFF HAS NOT RECEIVED MAQUET SANCTIONED SERVICE TRAINING ON THIS EQUIPMENT. MAQUET INC. SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A MAQUET LIGHT FELL DOWN IN THE OPERATING ROOM ONTO THE FLOOR. NO INJURIES WERE REPORTED. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SA FSY MAQUET S.A. AXCEL

    Patients

    Seq Age Sex Outcome Treatment
    1