BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET SAS

    MDR report key: 2335568 · Received November 3, 2011

    Report

    Report Number
    9710055-2011-00009
    Event Type
    Injury
    Date Received
    November 3, 2011
    Date of Event
    October 4, 2011
    Report Date
    October 5, 2011
    Manufacturer
    MAQUET SAS
    Product Code
    FTD
    PMA / PMN Number
    K932451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE TECH AUTHORIZED BY MAQUET VISITED THE HOSPITAL, EVALUATED THE DEVICE, AND FOUND THAT THE SAFETY RING OF THE SPRING ARM WAS CRACKED. THIS ALLOWED THE SAFETY SEGMENT (PIN) WHICH HOLDS THE LIGHT HEAD IN PLACE, TO BECOME DISLODGED. WITH THE SEGMENT OUT OF PLACE, THE LIGHT HEAD WAS NO LONGER SECURED TO THE SPRING ARM AND FELL. DURING THIS EVENT, THE SPRING ARM WAS DAMAGED AND MAQUET HAS RECOMMENDED THEIR REPLACEMENT. MAQUET SENT AN OFFER TO THE CUSTOMER FOR THE REPLACEMENT OF THE SPRING ARM. THE CUSTOMER HAS NOT RESPONDED TO THIS OFFER YET. THE USER MANUAL OF HLX 2000 INSTRUCTS THE OPERATORS OF THE LIGHT TO CHECK FOR THE PRESENCE OF CRACKS ON PLASTIC PARTS EVERY SIX MONTHS. MAQUET ALSO RECOMMENDS YEARLY PREVENTIVE MAINTENANCE OF THE LIGHT BY FACTORY AUTHORIZED SERVICE. HOWEVER, THIS FACILITY IS NOT UNDER A PREVENTIVE MAINTENANCE CONTRACT WITH MAQUET. THE HOSPITAL HAS ELECTED TO ASSUME RESPONSIBILITY FOR THE MAINTENANCE OF THESE LIGHTS. THE NURSE STRUCK BY THE LIGHT HEAD WAS A (B)(6) FEMALE, APPROX (B)(6). MAQUET HAS NOT BEEN INFORMED OF ANY SERIOUS INJURIES TO THE NURSE. IF ADD'L INFO ABOUT THE NURSE BECOMES AVAILABLE, A F/U REPORT WILL BE SUBMITTED. EXEMPTION # (B)(4). MAQUET INC. 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

    CUSTOMER REPORTED THAT DURING SURGICAL PROCEDURE, THE LIGHTHEAD DISENGAGED FROM THE SPRING ARM. DURING ITS DECENT, THE LIGHT HEAD STRUCK A NURSE ON THE FACE AND LEFT SHOULDER AND THEN HIT THE PT ON FOOT. ONLY MINOR INJURY TO PT REPORTED. ADD'L INFO ABOUT THE NURSE DOCUMENTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET SAS FTD MAQUET SAS HLX 2005

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other