BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 17928156 · Received October 12, 2023

    Report

    Report Number
    1317307-2023-00009
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 25, 2023
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889971019394
    PMA / PMN Number
    K191025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS. FOLLOW UP #1 (FINAL). CARESTREAM HEALTH INC (CSH) HAS EVALUATED THE DRX REVOLUTION SYSTEM. NO PATIENT INJURY OCCURRED. THE ISSUE IS CONFIRMED TO BE A COMPONENT FAILURE, THE SUPPORT BRACKET ON THE LEFT OF THE INVERTER BOARD GOT BROKEN AND IT IS SUSPECTED THAT IT TOUCHED THE POSITIVE POLE CONNECTOR ON THE INVERTER BOARD RESULTING IN A SHORT CIRCUIT ROUTING THE 240VDC TO THE FRAME GROUND. THE THERMAL EVENT IS NOT CONSIDERED A SAFETY RISK AS THIS THERMAL EVENT OCCURRED WITHIN THE SHEET METAL ENCLOSURE OF THE GENERATOR UNIT MAKING THE THERMAL EVENT SELF-CONTAINED WITHIN THE SYSTEM AND DID NOT BREACH THE OUTER WALLS (FOUR SIDES) OF THE REVOLUTION SYSTEM. CSH REPLACED AND INSTALLED A NEW GENERATOR. CSH HAS CONCLUDED 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. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.

    Description of Event or Problem · 0

    ON 27-SEP-2023, CARESTREAM HEALTH INC. WAS INFORMED THAT A CUSTOMER SITE REPORTED A THERMAL INCIDENT RELATED TO THE DRX REVOLUTION SYSTEM. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    ON (B)(6) 2023, CARESTREAM HEALTH INC. WAS INFORMED THAT A CUSTOMER SITE REPORTED A THERMAL INCIDENT RELATED TO THE DRX REVOLUTION SYSTEM. NO INJURIES REPORTED, THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749116 DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH INC. 60889971019394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other