BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LX2 CONTROL UNIT

    MDR report key: 18279484 · Received December 6, 2023

    Report

    Report Number
    3003899624-2023-00001
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 23, 2023
    Report Date
    December 6, 2023
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    PMA / PMN Number
    K033923
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EQUIPMENT IS 15+ YEARS OLD AND THOR HASVE NO RECORD THAT A SERVICE HAS BEEN CARRIED OUT FOR THIS LX2 CONTROL UNIT (SN (B)(6)).

    Description of Event or Problem · 0

    WHEN USING THE FIRST PLUG IN OF S1020 LX2 C CONTROL UNIT, SN (B)(6), WITH ANY OF THESE THREE PROBES: S1140 104 LED CLUSTER PROBE 660NM & 850NM 2W, S1160 810NM 1W CLUSTER (5X200MW) - ISSUE 1, OR S1092 810NM 200MW STANDARD TIP AFTER A FEW USES THE MACHINE STOPS WORKING. ONCE IT COOLS DOWN, IT RESUMES WORKING. THIS TAKES MAYBE 10 MINUTES. WHEN USING THE SECOND PLUG IN WITH ANY OF THESE PROBES, WITHIN 10 MINUTES OF USE THE PROBE GETS VERY HOT TO THE TOUCH, AND CAN'T BE USED BECAUSE IT WOULD PROBABLY BURN THE SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365961 LX2 CONTROL UNIT ILY THOR PHOTOMEDICINE LTD S1020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown