BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 16777101 · Received April 20, 2023

    Report

    Report Number
    1317307-2023-00005
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 21, 2023
    Report Date
    May 16, 2023
    Manufacturer
    CARESTREAM HEALTH INC.
    Product Code
    IZL
    UDI-DI
    60889971019394
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    505

    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 29 DAYS HAS ELAPSED. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS. FOLLOW UP #1 (FINAL) CARESTREAM HEALTH INC (CSH) HAS RECEIVED AND EVALUATED THE DRX REVOLUTION SYSTEM. NO PATIENT INJURY OCCURRED. 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 PUNCTURED BY A PIN FROM A COMPONENT ON THE CIRCUIT BOARD RESULTING IN A HIGH ENERGY SHORT CIRCUIT DUE TO VIBRATION OVER TIME. 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 WILL PROVIDE A SERVICE EXCHANGE OF THE SYSTEM. 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 AND AT LEAST 29 DAYS HAS ELAPSED. CSH WILL SUBMIT A FOLLOW UP WITH INVESTIGATION UPDATE/FINDINGS WITHIN 30 DAYS.

    Description of Event or Problem · 0

    ON 21-MAR-2023, CARESTREAM HEALTH INC. WAS INFORMED BY DEALER FE THAT A CUSTOMER SITE REPORTED A THERMAL INCIDENT RELATED TO THE DRX REVOLUTION SYSTEM. NO INJURIES REPORTED. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    ON (B)(6) 2023, CARESTREAM HEALTH INC. WAS INFORMED BY DEALER FE 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
    1205900 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