BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 19295803 · Received May 12, 2024

    Report

    Report Number
    1317307-2024-00005
    Event Type
    Injury
    Date Received
    May 12, 2024
    Date of Event
    April 13, 2024
    Report Date
    May 8, 2024
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889978618897
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 WAS DUE TO BAD OUTLET AND THE USE OF A NON-APPROVED PLUG. THE CUSTOMER HAD USED AN AFTERMARKET PLUG TIP ON THE CORD REEL AS THIS CUSTOMER IS SERVICED BY A THIRD PARTY (BIOMED). BIOMED DID NOT FOLLOW THE CAUTION WARNINGS OR GUIDANCE FROM THE PREVENTATIVE MAINTENANCE MANUAL AND HARDWARE GUIDE WHICH PROVIDES INFORMATION ON CARESTREAM APPROVED PARTS REPLACEMENT PROCESSES AND PARTS. THE CUSTOMER SITE WAS INFORMED OF THE FINDINGS AND CSH REITERATED TO FOLLOW THE GUIDELINES AND LIST OF APPROVED PARTS. THIS INCIDENT RESULTED IN THE TECH'S THUMB TO BE INJURED (BURN). CARESTREAM HAS BEEN UNABLE TO OBTAIN ADDITIONAL DETAILS REGARDING THE STATUS OF THE TECHNICIAN'S INJURY. THE DRX-REVOLUTION SYSTEM WAS EVALUATED, AND IT WAS CONFIRMED THAT IT WAS FUNCTIONING AS DESIGNED AND INTENDED. THERE ARE NO FURTHER ACTIONS TO BE TAKEN BY CARESTREAM HEALTH INC. RELATED TO THIS ISSUE. THE RISK HAS BEEN MITIGATED AS FAR AS POSSIBLE. CARESTREAM HAS COMPLETED THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM. THE PLUG ON THE POWER CORD WAS SMOKING WHEN UNPLUGGING THE UNIT FROM AN ELECTRICAL WALL OUTLET RESULTING IN THE TECH TO BURN HER THUMB. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    970691 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