BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCOMPASS ANORECTAL MANOMETRY CATHETER

    MDR report key: 18002755 · Received October 25, 2023

    Report

    Report Number
    18002755
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    August 31, 2023
    Report Date
    October 16, 2023
    Manufacturer
    MEDSPIRA, LLC
    Product Code
    KLA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PER THE MANAGER, THE NURSE AND THE TECHNICIAN WHO WERE DOING THE PROCEDURE NOTED THAT AN ERROR MESSAGE ABOUT THE CATHETER PRESSURE WHEN TRYING TO BLOW UP THE BALLOON. THEY REPORTED HAVING DIFFICULTY TROUBLESHOOTING THREE OF THESE CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151578 MCOMPASS ANORECTAL MANOMETRY CATHETER MONITOR, ESOPHAGEAL MOTILITY, AND TUBE KLA MEDSPIRA, LLC RMD-002-003 L-1103043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown