BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZVU HRIM PROBE

    MDR report key: 21084847 · Received January 6, 2025

    Report

    Report Number
    2023374-2024-00003
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    October 29, 2024
    Report Date
    December 23, 2004
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FFX
    UDI-DI
    00816734022689
    PMA / PMN Number
    K190208
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY DID CONTACT THE MANUFACTURER ON 29 OCTOBER 2024 PRIOR TO FILING A MEDWATCH REPORT WITH FDA (MW5162137). HOWEVER, BECAUSE THE MALFUNCTION REPORTED BY THE USER FACILITY DID NOT MEET THE CRITERIA FOR MANDATORY REPORTING, THE MANUFACTURER DID NOT FILE A REPORT WITH FDA AT THAT TIME. THIS REPORT IS IN RESPONSE TO THE USER FACILITY REPORT SENT TO THE FDA AND RECEIVED BY THE MANUFACTURER FROM FDA ON 29 NOVEMBER 2024. THE USER FACILITY REPORT REPORTED: 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 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. THE MANUFACTURER INVESTIGATED THIS COMPLAINT AND DETERMINED IT DID NOT MEET THE THRESHOLD FOR REPORTABILITY BECAUSE AN ADVERSE EVENT HAD NOT OCCURRED AND THE PRODUCT MALFUNCTION COULD NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE PRODUCT DESIGN HAS REDUNDANT SYSTEMS TO SECURE THE TIP IN THE EVENT OF BREAKAGE TO PREVENT SEPARATION. WHILE THIS BREAKAGE MAY CAUSE MINOR IRRITATION OF THE GI TRACT, IT WILL NOT CAUSE OR CONTRIBUTE TO A SERIOUS PATIENT INJURY. DIVERSATEK HEALTHCARE HAS DETERMINED THAT THERE ARE NO NEW SAFETY OR EFFICACY ISSUES AS A RESULT OF THIS EVENT AND THEREFORE, NO FURTHER ACTION WILL BE TAKEN.

    Description of Event or Problem · 0

    DESCRIPTION FROM MW5162137 VOLUNTARY USER REPORT: 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 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
    382751 ZVU HRIM PROBE SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE HRIM-201 00816734022689

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female