BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR PHOTOMEDICINE LTD

    MDR report key: 21478293 · Received February 27, 2025

    Report

    Report Number
    3003899624-2025-00002
    Event Type
    Malfunction
    Date Received
    February 27, 2025
    Date of Event
    February 1, 2025
    Report Date
    February 27, 2025
    Manufacturer
    THOR PHOTOMEDICINE LTD
    Product Code
    ILY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED AN ISSUE WITH GAS STRUTS FAILING TO OPERATE AS INTENDED. A VIDEO PROVIDED BY THE CUSTOMER SHOWS THE TOP OF THE BED CLOSING VERY SLOWLY WHEN LEFT OPEN UNATTENDED. NO ADVERSE EVENT HAS BEEN REPORTED, THERE HAVE BEEN NO PATIENT HARMS. THE NOVOTHOR FUNCTIONS AS NORMAL, IT CAN BE OPENED AND CLOSED AS NORMAL, PATIENTS CAN ENTER AND EXIT AND SAFELY HAVE TREATMENT INSIDE THE NOVOTHOR AS THIS ISSUE DOES NOT INTERFERE WITH THE PLACEMENT OR POSITION OF THE CANOPY. THOR HAS COMPLETED A HEALTH HAZARD EVALUATION WHICH FOUND THAT THE RISK OF THE MALFUNCTION CAUSING ANY HARM TO PATIENTS OR USERS OF THE DEVICE IS UNLIKELY AND WOULD BE MINIMAL, AND THEREFORE NO FIELD ACTION HAS BEEN INITIATED.

    Description of Event or Problem · 0

    CUSTOMER REPORTED GAS STRUTS ON THE NOVOTHOR XL BED SLOWLY CLOSE ON THEIR OWN WHEN LEFT UNATTENDED WITH A CONCERN THAT THIS WAS A SIGNIFICANT SAFETY HAZARD. THERE HAVE BEEN NO ADVERSE EVENTS OR HARMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616678 THOR PHOTOMEDICINE LTD NOVOTHOR XL ILY THOR PHOTOMEDICINE LTD S2190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown