BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 19180541 · Received April 25, 2024

    Report

    Report Number
    1317307-2024-00004
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    March 25, 2024
    Report Date
    May 22, 2024
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889978618897
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    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 CURRENTLY INSUFFICIENT FACTS AVAILABLE TO MAKE A REPORTABILITY DECISION AND AT LEAST 28 DAYS HAS ELAPSED. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.

    Additional Manufacturer Narrative · 0

    CARESTREAM HEALTH INC. (CSH) HAS INVESTIGATED THIS ISSUE AND ROOT CAUSE WAS UNABLE TO BE CONFIRMED; HOWEVER, IT WAS DETERMINED THAT THE MOST LIKELY REASON FOR THIS TO OCCUR COULD BE COPPER ENAMEL FAILURE IN THE AC ISOLATION TRANSFORMER RESULTING FROM VOLTAGE SURGES RELATED TO GEOGRAPHIC LOCATION OR DIRECT LIGHTNING STRIKING THE POWER SYSTEM. PER THE CUSTOMER, THIS RESULTED IN THE TECH TO BE SHOCKED; HOWEVER, PER THE INVESTIGATION THE DESCRIBED SHOCK WAS UNABLE TO BE CONFIRMED. CARESTREAM HAS BEEN UNABLE TO OBTAIN ADDITIONAL DETAILS REGARDING THE STATUS OF THE ALLEGED TECHNICIAN'S INJURY. THE CUSTOMER SITE WAS INFORMED OF THE FINDINGS AND CSH RECOMMENDED TO INSTALL SURGE PROTECTION FOR THE HOSPITAL SYSTEM TO PROTECT ALL THE DIFFERENT TYPES OF MEDICAL DEVICES AND SYSTEMS IN USE. 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 25-MAR-2024, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION PLUS MOBILE X-RAY SYSTEM. THE UNIT SPARKED WHEN PLUGGING THE UNIT INTO THE WALL RESULTING IN THE TECH TO BE SHOCKED. THE STATE OF INJURY IS UNKNOWN. NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING.

    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 UNIT SPARKED WHEN PLUGGING THE UNIT INTO THE WALL RESULTING IN THE TECH TO BE SHOCKED. THE STATE OF INJURY IS UNKNOWN. NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855183 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