BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZVU HRIM PROBE

    MDR report key: 20610238 · Received November 4, 2024

    Report

    Report Number
    MW5162137
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Report Date
    October 30, 2024
    Manufacturer
    DIVERSATEK HEALTHCARE INC.
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRIOR TO PATIENT: PROBE WAS TESTED UNDER THE CALIBRATION PROCESS AND APPEARED TO BE IN WORKING ORDER. ALL SENSORS WERE GREEN WHICH INDICATED ALL SENSORS WERE WORKING PROPERLY. PROBE INSERTED INTO R NARE WITHOUT DIFFICULTY. DATA REFLECTED ON SCREEN SHOWED THAT PROBE NEEDED INSERTED MORE AND THAT THERE WAS POSSIBLE COILING. PULLED PROBE OUT APPROXIMATELY 6 CM (IN ORDER TO FIX POSSIBLE COILING) AND THEN ADVANCED PROBE. PATIENT TOLERATED WELL. STILL DID NOT SEE ACCURATE DATA ON THE MONITOR (NEEDED ADVANCED MORE TO SEE THE OUTFLOW PORTION OF THE SWALLOW). SAT PATIENT UP TO ATTEMPT BETTER PLACEMENT AGAIN. PULLED PROBE OUT APPROXIMATELY HALFWAY AND PATIENT POINTED TO MOUTH (PROBE WAS NOW COILED IN HER MOUTH AFTER SOME MILD COUGHING/GAGGING). IT WAS DECIDED TO COMPLETELY REMOVE THE PROBE IN ORDER TO TRY A SECOND ATTEMPT. ONCE PROBE WAS REMOVED IT WAS IMMEDIATELY NOTICED THAT IT WAS BROKEN. PATIENT TOLERATED WELL. NO VISIBLE BLEEDING FROM MOUTH/NARES. SMALL AMOUNT OF BLOOD WAS NOTED ON PROBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460688 ZVU HRIM PROBE SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE INC. HRIM-201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female