BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET SAS

    MDR report key: 2434098 · Received January 24, 2012

    Report

    Report Number
    9710055-2012-00002
    Event Type
    Malfunction
    Date Received
    January 24, 2012
    Date of Event
    December 24, 2011
    Report Date
    December 27, 2011
    Manufacturer
    MAQUET S.A.S
    Product Code
    FTD
    PMA / PMN Number
    K932451
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECH (FST) INSPECTED THE DEVICE AND FOUND THAT THE SLEEVE SECURING THE LIGHT HEAD TO THE SPRING ARM WAS CRACKED, CAUSING THE RETAINING PIN TO MOVE OUT OF POSITION, AND FACILITATING THE DETACHMENT. THE FST REPLACED THE DAMAGED SLEEVE AND INSPECTED THE SLEEVES IN ALL THE OTHER ROOMS. THE HANAULUX 2000 SERIES OPERATING MANUAL MENTIONS THAT THE PRODUCT ARE TO BE INSPECTED BY THE OPERATOR EVERY SIX MONTHS WITH ATTENTION TO CRACKS IN PLASTIC PARTS. MAQUET IS NOT THE PRIMARY SERVICE PROVIDER OF THESE LIGHTS; THEY ARE MAINTAINED BY THE HOSPITAL BIOMEDICAL STAFF. (B)(4). MAQUET 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

    AFTER A PROCEDURE, A HOSPITAL EMPLOYEE WAS REPOSITIONING THE SURGICAL LIGHT WHEN IT DETACHED AND STRUCK HER IN THE HEAD. THE HOSPITAL EMPLOYEE WAS RUSHED TO THE HOSPITAL'S EMERGENCY DEPARTMENT. MAQUET WAS INFORMED THAT THE NURSE SUSTAINED A BLOW TO THE FOREHEAD WHICH RESULTED IN BLEEDING AND SWELLING. THE EXACT EXTENT OF ANY INJURY SUSTAINED HAS NOT BEEN REPORTED TO MAQUET AT THIS TIME. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS HANAULUX 2000 FTD MAQUET S.A.S HLX 2005 IXL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other