BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 12631162 · Received October 14, 2021

    Report

    Report Number
    1317307-2021-00006
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 18, 2021
    Report Date
    December 2, 2021
    Manufacturer
    CARESTREAM HEALTH
    Product Code
    IZL
    UDI-DI
    60889971019394
    PMA / PMN Number
    K191025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. CSH IS WAITING FOR THE SITE TO RELEASE THE DRX REVOLUTION SYSTEM SO THE DEALER CAN SHIP IT TO CSH IN THE U.S. FOR ANALYSIS/INVESTIGATION. CSH WILL SUBMIT A FOLLOW UP REPORT WITHIN THE REQUIRED TIMEFRAME. FOLLOW UP #1 - UPDATE: THE SYSTEM HAS BEEN SHIPPED BY THE KOREA DEALER AND HAS ARRIVED AT CARESTREAM HEALTH FOR FORENSIC EVALUATION THE WEEK OF 08-NOV-2021. CARESTREAM HEALTH INC. WILL PROVIDE A 2ND FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. CSH IS WAITING FOR THE SITE TO RELEASE THE DRX REVOLUTION SYSTEM SO THE DEALER CAN SHIP IT TO CSH IN THE U.S. FOR ANALYSIS/INVESTIGATION. CSH WILL SUBMIT A FOLLOW UP REPORT WITHIN THE REQUIRED TIMEFRAME. FOLLOW UP #1 - UPDATE: THE SYSTEM HAS BEEN SHIPPED BY THE KOREA DEALER AND HAS ARRIVED AT CARESTREAM HEALTH FOR FORENSIC EVALUATION THE WEEK OF 08-NOV-2021. CARESTREAM HEALTH INC. WILL PROVIDE A 2ND FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. FOLLOW UP #2 (FINAL REPORT): CARESTREAM HEALTH INC (CSH) HAS RECEIVED AND EVALUATED THE DRX REVOLUTION SYSTEM. THERE WAS EVIDENCE OF HEAT AND SMOKE BUT NO VISIBLE EVIDENCE OF FLAME. THE ISSUE IS CONFIRMED TO BE A THERMAL EVENT LINKED TO A COMMUNICATION & POWER INDUSTRIES INC. (CPI - MANUFACTURER) GENERATOR ISSUE, WHERE THE +120 VDC HIGH VOLTAGE (HV) CABLE INSULATION WAS MOST LIKELY PUNCTURED BY A PIN FROM CAPACITOR C51 RESULTING IN A HIGH ENERGY SHORT CIRCUIT. THE CPI GENERATOR (SERIAL # - (B)(6)) INSTALLED FOR THIS REVOLUTION SYSTEM (SERIAL # (B)(6)) WAS MANUFACTURED DECEMBER 2016, PRIOR TO THE IMPLEMENTATION OF CPI'S CORRECTIVE ACTIONS INITIATED IN FEB-2017. CPI BEGAN TO SHIP GENERATORS TO CARESTREAM WITH HV CABLES INSULATED WITH FIBERGLASS TO PREVENT PUNCTURES. NO THERMAL EVENTS OF THIS NATURE HAVE BEEN REPORTED TO CARESTREAM FOR REVOLUTION SYSTEMS WITH CPI GENERATORS MANUFACTURED AFTER FEB-2017 THUS INDICATING THE CORRECTIVE ACTIONS IMPLEMENTED BY CPI WERE EFFECTIVE. THE THERMAL EVENT IS NOT CONSIDERED A SAFETY RISK AS THIS FAILURE 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. THE EXCESSIVE HEAT GENERATED BY THE INTERNAL THERMAL EVENT WAS ENOUGH TO DAMAGE/MELT THE LOWER PORTION OF THE STORAGE CUP HOLDER ON THE UPPER REAR AREA OF THE UNIT WHICH IS STILL CONSIDERED TO BE SELF-CONTAINED WITHIN THE UNIT ITSELF. CSH WILL PROVIDE A SERVICE EXCHANGE OF THE SYSTEM. BASED ON THE FINDINGS, THERE WILL BE NO ADDITIONAL ACTIONS TAKEN. CSH HAS CONCLUDED THIS INVESTIGATION.

    Description of Event or Problem · 0

    ON 18-SEP-2021, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM WHICH OCCURRED AT (B)(6) HOSPITAL - KOREA. THE DEALER ALLEGED A THERMAL EVENT OCCURRED WITH THE DRX REVOLUTION SYSTEM. THREE INDIVIDUALS WITHIN THE VICINITY OF THE SYSTEM WERE TREATED FOR SMOKE INHALATION AND RELEASED THE SAME DAY WITH NO ADDITIONAL TREATMENT REQUIRED.

    Description of Event or Problem · 0

    ON 18-SEP-2021, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM WHICH OCCURRED AT EWHA WOMENS UNIVERSITY HOSPITAL - KOREA. THE CHANNEL PARTNER ALLEGED A THERMAL EVENT OCCURRED WITH THE DRX REVOLUTION SYSTEM. THREE INDIVIDUALS WITHIN THE VICINITY OF THE SYSTEM WERE TREATED FOR SMOKE INHALATION AND RELEASED THE SAME DAY WITH NO ADDITIONAL TREATMENT REQUIRED. PER THE CHANNEL PARTNER, THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. CSH IS WAITING FOR THE SITE TO RELEASE THE DRX REVOLUTION SYSTEM SO THE DEALER CAN SHIP IT TO CSH IN THE U.S. FOR ANALYSIS/INVESTIGATION. CSH WILL SUBMIT A FOLLOW UP REPORT WITHIN THE REQUIRED TIMEFRAME.

    Description of Event or Problem · 1

    ON (B)(6) 2021, CARESTREAM HEALTH (CSH) WAS INFORMED OF AN INCIDENT RELATED TO THE DRX-REVOLUTION MOBILE X-RAY SYSTEM WHICH OCCURRED AT (B)(6) HOSPITAL - (B)(6). THE DEALER ALLEGED A THERMAL EVENT OCCURRED WITH THE DRX REVOLUTION SYSTEM. THREE INDIVIDUALS WITHIN THE VICINITY OF THE SYSTEM WERE TREATED FOR SMOKE INHALATION AND RELEASED THE SAME DAY WITH NO ADDITIONAL TREATMENT REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528247 DRX-REVOLUTION MOBILE X-RAY SYSTEM DRX-REVOLUTION MOBILE X-RAY SYSTEM IZL CARESTREAM HEALTH 60889971019394

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other