BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET SAS

    MDR report key: 3080810 · Received April 9, 2013

    Report

    Report Number
    9710055-2013-00017
    Event Type
    Injury
    Date Received
    April 9, 2013
    Manufacturer
    MAQUET S.A.S
    Product Code
    FTD
    PMA / PMN Number
    K895715
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SVC TECH (FST) INSPECTED THE DEVICE AND FOUND THAT THE PLASTIC SLEEVE SECURING THE LIGHT HEAD TO THE SPRING ARM WAS CRACKED, WHICH ALLOWED THE RETAINING PIN TO MOVE OUT OF POSITION, AND FACILITATING THE DETACHMENT. THE FST REPLACED THE DAMAGED SLEEVE AND REPLACED THE SLEEVES IN ALL THE OTHER ROOMS. THE HANAULUX 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 # (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

    PLEASE REFERENCE IMP# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148261 MAQUET SAS FTD MAQUET S.A.S

    Patients

    Seq Age Sex Outcome Treatment
    1