BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C8I OCT INTEGRATED SYSTEM

    MDR report key: 10616201 · Received October 1, 2020

    Report

    Report Number
    3009600098-2020-00024
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    September 2, 2020
    Report Date
    December 20, 2020
    Manufacturer
    ST. JUDE MEDICAL CATD
    Product Code
    NQQ
    UDI-DI
    00183739000937
    PMA / PMN Number
    K188320
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO COMPONENT WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS A MANUFACTURING/DESIGN ISSUE IS NOT SUSPECTED AS THE DEVICE WAS MANUFACTURED IN 2016. THEREFORE, IT HAS EXCEEDED ITS DESIGN SERVICE LIFE EXPECTANCY OF TWO YEARS PER. THERE ARE NO SUSPECTED MANUFACTURING/DESIGN/NCMR/CAPA RELATED ISSUES TO REFERENCE AS A ROOT CAUSE COULD NOT BE DETERMINED. DUE TO LIMITED INFORMATION RECEIVED, ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR THE UNIT IS RECEIVED, THE DEVICE INVESTIGATION WILL BE UPDATED ACCORDINGLY.

    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

    THE DOC HOLSTER CAME OFF OF TABLE CLAMP AND THE WASHERS INSIDE SHORTED OUT THE CIRCUIT CAUSING THE PLASTIC TO MELT. NO PATIENT WAS INVOLVED IN THIS EVENT AND NO ADVERSE CONSEQUENCES OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079059 C8I OCT INTEGRATED SYSTEM SYSTEM, IMAGING, OPTICAL COHERENCE TOMOGRAPHY (OCT) NQQ ST. JUDE MEDICAL CATD 100106211 4786872 00183739000937

    Patients

    Seq Age Sex Outcome Treatment
    1 Other