BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XTEN

    MDR report key: 3871330 · Received April 22, 2014

    Report

    Report Number
    9710055-2014-00025
    Event Type
    Malfunction
    Date Received
    April 22, 2014
    Date of Event
    March 24, 2014
    Report Date
    March 24, 2014
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    PMA / PMN Number
    K040735
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET SERVICE TERRITORY MANAGER EVALUATED THE DEVICE. HE DETERMINED THAT THE METAL COVER IS PART OF THE ADJUSTMENT ARM; HE SECURED THE ORIGINAL METAL COVER TO THE SIDE PLASTIC COVERS OF THE SPRING ARM AND RETURNED THE UNIT TO SERVICE. THE ANALYSIS OF THE DEFECT SHOWS THAT THE METAL SLOT COVER MAY COME OUT OF THE SIDE PLASTIC COVER WHEN THE MOUNTING IS NOT CORRECT OR IF THE PLASTIC COVER GUIDES ARE NOT CORRECTLY ASSEMBLED. MOREOVER, ACCORDING TO THE XTEN OPERATING MANUAL, ANNUAL PREVENTIVE MAINTENANCE INCLUDES A VERIFICATION OF THE FASTENING OF SIDE PLASTIC COVERS. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE 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

    CUSTOMER CALLED FOR SERVICE ON THEIR LIGHT, STATING THAT A METAL COVER FELL OFF FROM THE SURGICAL LIGHT. THERE WAS NO PT INVOLVEMENT, NOR WERE ANY INJURIES REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243692 XTEN FSY MAQUET SAS XTEN NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI