BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX-EVOLUTION SYSTEM

    MDR report key: 17736223 · Received September 13, 2023

    Report

    Report Number
    1317307-2023-00007
    Event Type
    Injury
    Date Received
    September 13, 2023
    Date of Event
    July 23, 2023
    Report Date
    September 12, 2023
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    KPR
    UDI-DI
    60889971739193
    PMA / PMN Number
    K091889
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023, THE BUSINESS PARTNER (BP) MEDRAY, INFORMED CARESTREAM HEALTH THAT A SITE EXPOSED A PATIENT MORE THAN 10X THE EXPECTED DOSE. PER THE INVESTIGATION, IT WAS DETERMINED THAT THE USER ADDED A WRONG VIEW TO A CHEST EXAM BY MISTAKE CAUSING THE OVEREXPOSURE. ROOT CAUSE: THE OPERATOR HAD ADDED A HIP VIEW TO A CHEST EXAM, DUE TO THIS, THE LOCATION DEFAULTED TO WALL STAND WITH DETECTOR INSTEAD OF TABLE WITH DETECTOR. THIS RESULTED IN LARGE MAS AND THE OPERATOR DID NOT VERIFY THE EXPOSURE PARAMETERS WHEN REVIEWING THE PROPER WORKSPACE SELECTION. THE OPERATOR HAD ENOUGH TIME TO CHECK THE TECHNIQUES ON THE SCREEN. THEY DIDN'T CHECK TECHNIQUES BEFORE EXPOSING. THE BUSINESS PARTER APPLICATIONS WENT ON SITE AND EXPLAINED TO THE CUSTOMER THE CORRECT TECHNIQUES TO BE USED. THE FE REITERATED THAT THE TECH SHOULD VERIFY ALL TECHNIQUES BEFORE EXPOSING. PER OUR RADIATION SAFETY REPRESENTATIVE, AND BASED ON THE TECHNIQUES USED FOR THE EXPOSURE, THE RISK TO THIS PEDIATRIC PATIENT IS MINIMAL. THE ADDITIONAL RADIATION DOSE IS WELL BELOW THAT WHICH WOULD RESULT IN ANY PROMPT EFFECTS LIKE SKIN ERYTHEMA, AND THE ADDITIONAL RISK FROM STOCHASTIC EFFECTS IS NEGLIGIBLE. THE SYSTEM IS CURRENTLY IN USE. THIS WAS A ONE TIME EVENT. THERE HAVE BEEN NO RE-OCCURRENCES. CSH HAS CONCLUDED THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE BUSINESS PARTNER (BP) MEDRAY, INFORMED CARESTREAM HEALTH THAT A SITE EXPOSED A PATIENT MORE THAN 10X THE EXPECTED DOSE. EXPECTED DOSE: 100 KV, 28MAS. GIVEN DOSE: 100 KV, 353.2MAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1789199 DRX-EVOLUTION SYSTEM DRX-EVOLUTION SYSTEM KPR CARESTREAM HEALTH INC. 60889971739193

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other