BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLED

    MDR report key: 5233708 · Received November 18, 2015

    Report

    Report Number
    9710055-2015-01028
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 5, 2015
    Manufacturer
    MAQUET SAS
    Product Code
    FSY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NOVEMBER 18, 2015 10:04 AM (GMT-5:00) ADDED BY (B)(6): A MAQUET FIELD SERVICE TECHNICIAN (FST) EVALUATED THE DEVICE. THE CAUSE OF THIS EVENT IS THE CLIP ¿ PART OF THE LOCKING SYSTEM FROM THE HANDLE SUPPORT - HAS BROKEN AND THEN DISLODGED FROM ITS LOCATION WHILE USER WAS MANIPULATING THE LIGHT. MAQUET IS NOT ABLE TO EVALUATE THE BROKEN CLIP AS IT HAS BEEN DISCARDED BY THE USERS. THE FST REPLACED THE HANDLE WITH A NEW ONE AND RETURNED THE DEVICE TO SERVICE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE LOCKING MECHANISM FROM THE HANDLE SUPPORT BROKE DURING THE CLEANING PROCESS. NO INJURIES WERE REPORTED, THERE WAS NO PATIENT INVOLVEMENT. (B)(4). MAQUET IS AWARE OF A TOTAL OF 4 SIMILAR EVENTS INVOLVING 4 SEPARATE DEVICES. THESE 4 EVENTS ARE BEING REPORTED IN 4 MDR'S UNDER THE FACTORY REFERENCE NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763446 HLED LIGHT, SURGICAL, CEILING MOUNTED FSY MAQUET SAS HLD73SFK4

    Patients

    Seq Age Sex Outcome Treatment
    1