BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACQUISITION INSIGHT ULTIMA MANOMETRY SYSTEM

    MDR report key: 8712072 · Received June 18, 2019

    Report

    Report Number
    MW5087436
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    June 11, 2019
    Report Date
    June 14, 2019
    Manufacturer
    DIVERSATEK HEALTHCARE / SANDHILL SCIENTIFIC
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    UNABLE TO INITIATE THE USE OF THE SANDHILL SCIENTIFIC. INSIGHT ULTIMA, MANOMETRY SYSTEM AFTER NUMEROUS ATTEMPTS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503814 ACQUISITION INSIGHT ULTIMA MANOMETRY SYSTEM SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE / SANDHILL SCIENTIFIC H12R-2000 DISC007B
    503815 ACQUISITION INSIGHT ULTIMA MANOMETRY SYSTEM SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE / SANDHILL SCIENTIFIC H12R-4500 CISC002D

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR