BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILUMIEN OPTIS IMAGING SYSTEM PIU 2.2

    MDR report key: 11174624 · Received January 14, 2021

    Report

    Report Number
    3009600098-2021-00002
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 29, 2020
    Report Date
    April 28, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NQQ
    UDI-DI
    00183739000678
    PMA / PMN Number
    K123369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PIU WAS RECEIVED FOR EVALUATION. PRODUCT ANALYSIS REVEALED THE REPORTED ISSUE COULD BE DUPLICATED. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS A MANUFACTURING/DESIGN ISSUE IS NOT SUSPECTED AS THE DEVICE WAS MANUFACTURED IN 2013. THEREFORE, IT HAS EXCEEDED ITS DESIGN SERVICE LIFE EXPECTANCY OF TWO YEARS. THEREFORE THE FAILURE WAS DETERMINED TO BE NORMAL WEAR AND TEAR. THERE ARE NO PREVIOUS COMPLAINTS FOR THIS ISSUE ASSOCIATED WITH THIS SERIAL NUMBER AND THE UNIT HAS NOT BEEN PREVIOUSLY RETURNED FOR REFURBISHMENT. BASED ON THE RESULTS OF THE HARDWARE ANALYSIS, THE ROOT CAUSE OF THE REPORTED ISSUE WAS DUE TO THE DAMAGED ENGINE CABLE.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, A CANCELLATION OCCURRED. THE PATIENT WAS IN-PATIENT OVERNIGHT FOR A PLANNED ANGIOGRAM AND OCT. AN ERROR MESSAGE APPEARED ON THE SYSTEM STATING "A SERIOUS ERROR HAS OCCURRED (111). THERE IS A PROBLEM COMMUNICATING WITH THE DOC. CLICK OK TO SHUT DOWN THE OCT SYSTEM." THE SYSTEM WAS RESTARTED AND ANOTHER ERROR MESSAGE APPEARED THAT STATED "CONFIGURATION ERROR (1337). INVALID HARDWARE CONFIGURATION. CONTACT YOUR AUTHORIZED SERVICE REPRESENTATIVE. DOC ERROR." THE ANGIOGRAM WAS CANCELLED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65825 ILUMIEN OPTIS IMAGING SYSTEM PIU 2.2 SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ ABBOTT VASCULAR 15200-01 4419528 00183739000678

    Patients

    Seq Age Sex Outcome Treatment
    1 Other