BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3201523 · Received June 26, 2013

    Report

    Report Number
    9710055-2013-00026
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MAQUET S.A.S
    Product Code
    FSY
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE TECH (FST) VISITED THE CUSTOMER TO CHECK THE INVOLVED EQUIPMENT. THE FST OBSERVED THAT THE RETAINING SCREW WAS MISSING; ENABLING THE SAFETY SLEEVE TO MOVE OUT OF POSITION. THE DEVICE MANUAL AND PRODUCT LABELING INSTRUCTS THE OPERATOR THAT THE SLEEVE MUST BE IN PLACE PRIOR TO USE. THE FST VERIFIED THAT THERE WAS NO DAMAGED COMPONENTS AND RE-INSTALLED THE CUPOLA, WITH A NEW SCREW. (B)(4). MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. MAQUET HAS PROVIDED PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    REF IMPORTER NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290482 MAQUET SAS NA FSY MAQUET S.A.S

    Patients

    Seq Age Sex Outcome Treatment
    1