BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 18383727 · Received December 22, 2023

    Report

    Report Number
    1317307-2023-00013
    Event Type
    Injury
    Date Received
    December 22, 2023
    Date of Event
    October 30, 2023
    Report Date
    December 21, 2023
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    PMA / PMN Number
    K191025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH HAS EVALUATED THE DEVICE. THE INVESTIGATION DETERMINED THAT THE CUSTOMER IS CONTINUALLY LEAVING THE SYSTEM UNPLUGGED. THE DATE OF THE INCIDENT WAS THE LAST DEEP DISCHARGE OF THE BATTERIES - REACHING A LOW CHARGE LEVEL OF 1. IT IS KNOWN THAT THE BATTERY SERVICE LIFE IS SIGNIFICANTLY REDUCED IF THEY ARE DEEPLY DISCHARGED MULTIPLE TIMES. CARESTREAM'S ENGINEERING TEAM HAS CONCLUDED THAT THERE WAS NO DEVICE MALFUNCTION AND THE UNIT WAS WORKING AS DESIGNED AND INTENDED; THIS INCIDENT WAS CAUSED DUE TO CUSTOMER CHARGING PRACTICES. THE HEALTH OUTCOME OF THE PATIENT WAS NOT RELATED TO THE UNIT. THE FE REITERATED TO THE SITE TO CHARGE THE SYSTEM AS RECOMMENDED AND ADVISED TO KEEP THE SYSTEM ON AC POWER WHEN NOT IN USE. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH RELATED TO THIS ISSUE. CARESTREAM HAS COMPLETED THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON 27-NOV-2023, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM THAT OCCURRED ON (B)(6) 2023 (A MONTH AGO). THE TECH ATTEMPTED TO MAKE AN EXPOSURE ON A SERIOUSLY INJURED PATIENT BUT THE UNIT WOULD NOT SHOOT. THE TECH RETRIEVED A SECOND UNIT TO EXPOSE THE PATIENT; HOWEVER, BY THIS TIME, THE PATIENT PASSED. THE STATE OF INJURY PRIOR TO THE INCIDENT IS UNKNOWN. UDI: N/A. SYSTEM MANUFACTURED PRIOR TO UDI IMPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569826 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other