BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 19381839 · Received May 23, 2024

    Report

    Report Number
    1317307-2024-00006
    Event Type
    Malfunction
    Date Received
    May 23, 2024
    Date of Event
    April 24, 2024
    Report Date
    June 5, 2024
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889978618897
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH INC. (CSH) HAS INVESTIGATED THIS ISSUE AND IT WAS DETERMINED THAT THIS INCIDENT WAS DUE TO A DOCK MECHANISM ISSUE. THE REVOLUTION SYSTEM IS DESIGNED TO DRIVE AT VERY LOW SPEED WHEN THE TUBE COLUMN IS UNDOCKED. IN THIS CASE, THE DOCKING MECHANISM WAS INCORRECTLY PROVIDING A SIGNAL OF "UNDOCKED CONDITION" WHILE DRIVING, CAUSING THE UNIT TO COME TO A STOP AS DESIGNED. ALTHOUGH THE UNIT CONTACTED THE PATIENT, IT DID NOT RESULT IN AN INJURY. THE LATCH ROTARY ASSEMBLY AND THE CABLE-MAC TO BOOM LOCK AND COLUMN DOWN SENSOR WERE REPLACED. BREAK-FIX. THE SYSTEM IS CURRENTLY IN USE WITH NO RE-OCCURENCES. THIS TYPE OF RISK IS ALREADY INCLUDED IN THE RISK ASSESSMENT AND CONTROL MATRIX OF THE PRODUCT. THE RISK HAS BEEN MITIGATED AS FAR AS POSSIBLE. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH INC. RELATED TO THIS ISSUE. CARESTREAM HAS COMPLETED THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CSH INVESTIGATION IS CURRENTLY IN PROGRESS. SUBMITTING AN INITIAL REPORT AS THERE ARE CURRENTLY INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION AND AT LEAST 28 DAYS HAVE ELAPSED. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF WAS INFORMED OF AN UNINTENDED MOVEMENT WHILE USING THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF WAS INFORMED OF AN UNINTENDED MOVEMENT WHILE USING THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616478 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC. 60889978618897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other