BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAQUET SA

    MDR report key: 1746497 · Received July 1, 2010

    Report

    Report Number
    9710055-2010-00010
    Event Type
    Other
    Date Received
    July 1, 2010
    Date of Event
    June 3, 2010
    Report Date
    June 3, 2010
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    PMA / PMN Number
    K982063
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET TECHNICIANS (FST) WERE ON SITE TO ADDRESS AN ISSUE ON ANOTHER DEVICE AND CHECKED THE LIGHT THAT FELL AT THE REQUEST OF THE CUSTOMER. UPON ARRIVAL, THE FST FOUND ALL THE SCREWS IN THE DOWNTUBE WITH THREAD SHOWING. WHEN MOVING THE LIGHTING ASSEMBLY ARMS, THE UNIT DETACHED FROM THE DOWNTUBE. AFTER THE INCIDENT, THE LIGHT WAS REMOVED FROM SERVICE. IT IS BELIEVED THAT BECAUSE THE LIGHT HAD NOT BEEN MAINTAINED PER OPERATIONS MANUAL (PRISMALIX NTR 011323003 ED 3E,) THE DIN 916 AND THE DIN 915 SCREW WERE ABLE TO LOOSEN AND BACK OUT OVER TIME LEADING TO THIS EVENT. WITH THESE SCREWS OUT OF POSITION, AN EXTRAORDINARY AMOUNT OF FORCE WAS APPLIED TO THE DIN915 SCREW DETERIORATING THE THREADS OF BOTH THE SCREW AND ANCHORING TUBE. THE EXTENDED SCREW ALSO WIDENED DOWNTUBE OPENING. MAQUET SERVICE REPLACED ALL DAMAGED COMPONENTS AND RETURNED LIGHT TO SERVICE. MAQUET FST HAVE INSPECTED THE OTHER MAQUET LIGHTS AT THIS FACILITY, ENSURING THAT ANY LOOSE SCREWS FOUND WERE SECURED. (B)(4) SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET S.A. PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    MAQUET HAS BEEN NOTIFIED THAT DURING A MAINTENANCE INSPECTION OF THE SURGICAL LIGHT, THE LIGHTING ASSEMBLY CAME LOOSE FROM ITS CEILING SUPPORT. THE SERVICE TECHNICIAN INSPECTING THE LIGHT WAS ABLE TO STOP THE FALL OF THE UNIT, SUSTAINING AN INJURY TO HIS BACK IN THE PROCESS. THIS INJURY DID NOT REQUIRE A HOSPITALIZATION OR ANY ADDITIONAL TREATMENT. NO ADVERSE HEALTH CONSEQUENCES HAVE BEEN REPORTED BY THE CUSTOMER. (B)(4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1