BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SANDHILL SCIENTIFIC INSIGHT ULTIMA

    MDR report key: 9234865 · Received October 24, 2019

    Report

    Report Number
    2183446-2019-00002
    Event Type
    Malfunction
    Date Received
    October 24, 2019
    Date of Event
    June 11, 2019
    Report Date
    August 20, 2019
    Manufacturer
    DIVERSATEK HEALTHCARE
    Product Code
    FFX
    UDI-DI
    00816734021941
    PMA / PMN Number
    K012232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT MEDWATCH REPORT MW5087436 DOES NOT CONTAIN ENOUGH INFORMATION TO DO A COMPLETE INVESTIGATION. MW5087436 STATES: "UNABLE TO INITIATE THE USE OF THE SANDHILL SCIENTIFIC INSIGHT ULTIMA MANOMETRY SYSTEM AFTER NUMEROUS ATTEMPTS". A REVIEW OF ALL COMPLAINT RECORDS SHOWED THIS CUSTOMER DID NOT REPORT THIS EVENT TO THE (B)(4) HEALTHCARE. CUSTOMER WAS CONTACTED FOR ADDITIONAL INFORMATION BUT NONE WAS PROVIDED. THE FIRST STEP FOR USE OF THE ULTIMA IS TO TURN IT ON AND CONNECT IT TO A MANOMETRY PROBE OUTSIDE THE PATIENT. CALIBRATION OF THE PROBE IS THEN PERFORMED. IF THE USER COULD NOT INITIATE USE OF THE ULTIMA UNIT, A PATIENT WAS NOT INVOLVED IN THIS EVENT. THEREFORE, IT IS UNKNOWN WHY THIS WAS REPORTED AS IT DOES NOT MEET THE THRESHOLD FOR A REPORTABLE EVENT. ADDITIONALLY, IF THE ULTIMA WERE TO FAIL DURING A MANOMETRY STUDY, IT WOULD POSE NO SAFETY RISK TO THE PATIENT. BASED ON A REVIEW OF TRENDING REPORTS AND THE INFORMATION AVAILABLE, THE DEVICE DOES NOT POSE A SAFETY RISK EVEN IF USE CANNOT BE INITIATED. ADDITIONALLY, PATIENT INVOLVEMENT BEGINS AFTER THE ULTIMA HAS BEEN STARTED, SO THE INABILITY TO INITIATE USE WOULD NEVER INVOLVE A PATIENT. (B)(4) 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 · 1

    PER CUSTOMER REPORT MW5087436 "UNABLE TO INITIATE THE USE OF THE SANDHILL SCIENTIFIC INSIGHT ULTIMA, MANOMETRY SYSTEM AFTER NUMEROUS ATTEMPTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1028760 SANDHILL SCIENTIFIC INSIGHT ULTIMA GASTROINTETINAL MOTILITY MONITORING SYSTEM FFX DIVERSATEK HEALTHCARE H12R-2000 N/A 00816734021941

    Patients

    Seq Age Sex Outcome Treatment
    1 Other