BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    500 XLE OPHTHALMIC SURGERY EYE CHAIR

    MDR report key: 20383801 · Received October 7, 2024

    Report

    Report Number
    20383801
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    August 21, 2024
    Report Date
    September 27, 2024
    Manufacturer
    UFSK-INTERNATIONAL OSYS GMBH
    Product Code
    HME
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGICAL EYE CHAIR MALFUNCTIONED AND BURNING SMELL & SMALL AMOUNT OF SMOKE NOTED AT CORD AND BATTERY CONNECTION POINT, CHAIR WAS SWAPPED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283353 500 XLE OPHTHALMIC SURGERY EYE CHAIR CHAIR, OPHTHALMIC, AC-POWERED HME UFSK-INTERNATIONAL OSYS GMBH 15000004 500 XLE

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Female