BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 3142283 · Received May 15, 2013

    Report

    Report Number
    9710055-2013-00022
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Manufacturer
    MAQUET S.A.
    Product Code
    FTD
    PMA / PMN Number
    K895715
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED PHOTOS OF THE AFFECTED DEVICE, BUT LITTLE INFO CONCERNING THE EVENT. THE PLASTIC SLEEVE SECURING THE LIGHT HEAD TO THE SPRING ARM WAS CRACKED, WHICH CAN ALLOW THE RETAINING PIN TO MOVE OUT OF POSITION, ENABLING THE REPORTED DETACHMENT. THE NANAULUX 2000 SERIES OPERATING MANUAL MENTIONS THAT THE PRODUCTS ARE TO BE INSPECTED BY THE OPERATOR EVERY SIX MONTHS WITH ATTENTION TO CRACKS IN PLASTIC PARTS. MAQUET IS NOT THE PRIMARY SVC PROVIDER OF THESE LIGHTS; THEY ARE MAINTAINED BY THE HOSPITAL BIOMEDICAL STAFF. EXEMPTION NUMBER: (B)(4) MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MFG FACILITY. (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    REF NUMBER3008355164-2013-00105.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215896 MAQUET SAS FTD MAQUET S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1