BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROPHON EPR

    MDR report key: 21737986 · Received April 1, 2025

    Report

    Report Number
    21737986
    Event Type
    Malfunction
    Date Received
    April 1, 2025
    Date of Event
    March 26, 2025
    Report Date
    March 27, 2025
    Manufacturer
    NANOSONICS LIMITED
    Product Code
    OUJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    AT DISINFECTING CYCLE OF THE MR [MAGNETIC RESONANCE] FUSION PROBE, MACHINE READ "FAILED". THE PROBES WERE SWITCHED OUT, CYCLE RAN AGAIN AND READ: "FAILED"; BIO MED PICKED UP THE MACHINE, REPLACED A PART, RETESTED THE MACHINE, PROBLEM RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1171068 TROPHON EPR HIGH LEVEL DISINFECTION REPROCESSING INSTRUMENT FOR ULTRASONIC TRANSDUCERS OUJ NANOSONICS LIMITED N00010-US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown