BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INNOVA 21 EPI

    MDR report key: 16673390 · Received April 4, 2023

    Report

    Report Number
    16673390
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    August 4, 2022
    Report Date
    September 21, 2022
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    GE X-RAY SYSTEM FAILED MID-PROCEDURE IN THE EP LAB. SYSTEM REBOOTS DID NOT CORRECT THE PROBLEM. PATIENT WAS TRANSFERRED WITH STERILE FIELD KEPT INTACT TO CATH LAB #1 TO COMPLETE THE PROCEDURE. NO EVIDENT NEGATIVE IMPACTS TO PATIENT OUTSIDE OF PROCEDURE TIME DELAY OF ROUGHLY 15 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385929 INNOVA 21 EPI SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED JAA GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 22630 DA Female