BEUDAMED
    FDA Adverse Event Summary report: N

    CARESTREAM HEALTH INC DRX-REVOLUTION

    MDR report key: 8316988 · Received February 7, 2019

    Report

    Report Number
    MW5083826
    Date Received
    February 7, 2019
    Date of Event
    October 3, 2018
    Report Date
    January 22, 2019
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    KPR
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTED PROBLEM: UNIT CAUGHT FIRE DURING PHYSICS TESTING. CARESTREAM¿S INVESTIGATION FOUND THAT THE REPORTED FIRE WAS ACTUAL HIGH ENERGY ELECTRICAL ARCING OCCURRING ON THE GENERATOR¿S INVERTER BOARD. THE HIGH ENERGY ARCING OCCURRED AS A RESULT OF A CATASTROPHIC FAILURE OF TWO FIELD EFFECT TRANSISTORS (FETS) LOCATED ON THE GENERATOR¿S INVERTER BOARD. ONCE THE FETS FAILED, THE SYSTEM BLEW A FUSE INTENDED TO HALT THE FLOW OF ENERGY TO THE DAMAGED BOARD. THE FUSE HOWEVER, BLEW IN A WAY THAT ALLOWED CURRENT TO BYPASS THE FUSE BLOCK THEREBY SUSTAINING THE EVENT. THE EVENT WAS TERMINATED, WHEN THE SYSTEMS CIRCUIT BREAKER WHICH SERVES AS A SECONDARY SAFETY COMPONENT FOR THIS TYPE OF FAILURE WAS MANUALLY SWITCHED OFF. ONCE THE SYSTEMS CIRCUIT BREAKER WAS TURNED OFF, CURRENT FLOW TO THE DAMAGED BOARD HALTED AND THE THERMAL EVENT CAME TO AN END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107010 CARESTREAM HEALTH INC DRX-REVOLUTION SYSTEM. X-RAY, STATIONARY KPR CARESTREAM HEALTH, INC. DRXR-1

    Patients

    Seq Age Sex Outcome Treatment
    1