BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOTIP INSIGHT

    MDR report key: 21383521 · Received February 14, 2025

    Report

    Report Number
    21383521
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 27, 2025
    Report Date
    February 4, 2025
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QIJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHOTOPLETHYSMOGRAPHY (PPG) TEST TO BE COMPLETED. TEST RESULT OUTSIDE OF NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    982370 ECHOTIP INSIGHT ENDOSCOPIC TRANSHEPATIC VENOUS ACCESS NEEDLE QIJ COOK IRELAND LTD G46560 C2235251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown