BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESTREAM DRX EVOLUTION PLUS SYSTEM

    MDR report key: 18728694 · Received February 18, 2024

    Report

    Report Number
    1317307-2024-00001
    Event Type
    Injury
    Date Received
    February 18, 2024
    Date of Event
    January 29, 2024
    Report Date
    February 15, 2024
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    KPR
    PMA / PMN Number
    K091889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CSH INVESTIGATION IS CURRENTLY IN PROGRESS. SUBMITTING AN INITIAL REPORT AS THERE ARE INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.

    Description of Event or Problem · 0

    ON 1-FEB-2024, CARESTREAM HEALTH INC. WAS INFORMED OF AN UNINTENDED MOVEMENT OF THE OVERHEAD TUBE CRANE (OTC) WHILE USING THE DRX-EVOLUTION SYSTEM. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463940 CARESTREAM DRX EVOLUTION PLUS SYSTEM CARESTREAM DRX EVOLUTION PLUS SYSTEM KPR CARESTREAM HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other