BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANAULUX 2000

    MDR report key: 4102601 · Received August 28, 2014

    Report

    Report Number
    9710055-2014-00065
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 1, 2014
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    PMA / PMN Number
    K895715
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED PHOTOS OF THE AFFECTED DEVICE, BUT LITTLE INFORMATION CONCERNING THE EVENT. THE PLASTIC SLEEVE SECURING THE LIGHT HEAD TO THE SPRING ARM WAS BROKEN, WHICH CAN ALLOW THE RETAINING PIN TO MOVE OUT OF POSITION, ENABLING THE REPORTED DETACHMENT. 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 INFORMED IF MAINTENANCE HAS BEEN DONE ON THE DEVICE. MAQUET MEDICAL SYSTEMS USA SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO MAQUET THAT THE SAFETY SEGMENT FELL DOWN ALLOWING THE 2005TV LIGHTHEAD TO DETACH. THE LIGHTHEAD WAS STILL HANGING BY ITS WIRES. NO INJURIES HAVE BEEN REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523985 HANAULUX 2000 FTD MAQUET SAS HANAULUX 2000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA