BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3150227 · Received May 1, 2013

    Report

    Report Number
    9710055-2013-00018
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Manufacturer
    MAQUET S.A.S
    Product Code
    FSY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED AS THE 3000 SERIES LIGHT SHARES A COMMON DESIGN WITH DEVICES MARKETED BY MAQUET IN THE UNITED STATES. THE HANAULUX 3000 SERIES IS NOT SOLD IN THE UNITED STATES. A MAQUET MAINTENANCE TECHNICIAN VISITED THE HOSPITAL AND FOUND THE FRONT PIVOT OF THE SPRING ARM BROKEN. HE REPLACED THE SPRING ARM WITH A NEW ONE AND RETURNED THE UNIT TO SERVICE. EXEMPTION # (B)(4). MAQUET MEDICAL SYSTEMS USA 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

    IMP REF #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190744 MAQUET SAS NA FSY MAQUET S.A.S

    Patients

    Seq Age Sex Outcome Treatment
    1