BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 23066953 · Received September 16, 2025

    Report

    Report Number
    3013401749-2025-00004
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    July 16, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE MACHINE WAS SMOKING AND BURNING. THE CUSTOMER CHANGED THE FUSE, BUT THE MACHINE WOULD NOT TURN ON. THE POWER CORD WAS CONFIRMED TO BE OKAY. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2659627 MICROTEK IRRIGATION SOLUTION WARMER, 6.6 LITER LHC MICROTEK MEDICAL LLC ORS-2066R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown