BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 23063840 · Received September 16, 2025

    Report

    Report Number
    3013401749-2025-00003
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    July 3, 2025
    Report Date
    September 16, 2025
    Manufacturer
    MICROTEK MEDICAL LLC
    Product Code
    LHC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPROTED THAT THE SLUSH MACHINE WAS TURNED ON AT 5:15 AM. AT 7:00 AM IT WAS STILL NOT MAKING ICE LIKE IT SHOULD HAVE. HAD TO GET ANOTHER MACHINE IN ORDER TO START THE PROCEDURE.NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2660254 MICROTEK HUSH SLUSH SURGICAL SLUSH MACHINE LHC MICROTEK MEDICAL LLC ORS-1075HS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male