BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3201479 · Received June 26, 2013

    Report

    Report Number
    9710055-2013-00027
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MAQUET S.A.
    Product Code
    FSY
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE CUSTOMER, AN ACCIDENTAL IMPACT OCCURRED, CAUSING THE CAMERA TO DETACH. THE HOSPITAL DID NOT GIVE FURTHER DETAILS CONCERNING THIS EVENT. (B)(4). MAQUET MEDICAL SYSTEMS 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

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290178 MAQUET SAS NONE FSY MAQUET S.A. HLED NA

    Patients

    Seq Age Sex Outcome Treatment
    1