BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2578141 · Received April 27, 2012

    Report

    Report Number
    9710055-2012-00008
    Event Type
    Malfunction
    Date Received
    April 27, 2012
    Date of Event
    March 30, 2012
    Report Date
    March 31, 2012
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    PMA / PMN Number
    K932451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) VISITED THE FACILITY AND REPLACED THE BROKEN SPRING ARM WITH A NEW ONE. THE FST INSPECTED THE WELDS ON ALL REMAINING MAQUET SURGICAL LIGHTS. THE WELDED SEAMS WERE SECURE, NO CRACKS OR TEARS WERE OBSERVED. THE BROKEN SPRING ARM WAS PREVIOUSLY INSPECTED BY A MAQUET TECHNICIAN IN (B)(4) 2011, AS PART OF THE YEARLY MAINTENANCE PROGRAM. NO DAMAGE TO THE WELD SEAM WAS DETECTED AT THAT TIME. THIS MALFUNCTION WAS PREVIOUSLY ADDRESSED IN THE U.S. THROUGH A DEVICE CORRECTION: (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET SAS PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MAQUET THAT THE SURGICAL LIGHT SPRING ARM BROKE JUST BEFORE A SURGERY. THE HOSPITAL DID NOT REPORT INJURIES. THE CUPOLA WAS RETAINED BY THE CABLING. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS FTD MAQUET SAS HANAULUX 2000

    Patients

    Seq Age Sex Outcome Treatment
    1