BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZEPHR

    MDR report key: 19816513 · Received July 24, 2024

    Report

    Report Number
    19816513
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    May 16, 2024
    Report Date
    May 17, 2024
    Manufacturer
    DIVERSATEK HEALTHCARE, INC.
    Product Code
    FFX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE IMPEDANCE MACHINE WOULD NOT FUNCTION, AND REGISTERED NURSE (RN) DID NOT HAVE A REPLACEMENT MACHINE TO USE, SO THE IMPEDANCE CATHETER WAS NOT PLACED AS PLANNED. VENDOR WAS CALLED TO LET THEM KNOW THAT THE MACHINE NEEDS REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2370549 ZEPHR SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) FFX DIVERSATEK HEALTHCARE, INC. Z07-2000-B-B L139009C

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Male