BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX-1 SYSTEM

    MDR report key: 2607556 · Received June 4, 2012

    Report

    Report Number
    1317307-2012-00002
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Date of Event
    May 10, 2012
    Report Date
    May 24, 2012
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    MQB
    PMA / PMN Number
    K090318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED BATTERY IS ONGOING - FAILURE ANALYSIS IS NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE PT WAS BROUGHT TO AN X-RAY ROOM IN THE HOSPITAL ON A PORTABLE BED FOR A CHEST X-RAY. BECAUSE THE PT WAS UNABLE TO STAND, A GE MOBILE X-RAY SYSTEM WITH A CARESTREAM DRX-1 DETECTOR (FLAT PANEL DIGITAL IMAGER) WAS BROUGHT INTO THE X-RAY ROOM TO PERFORM THE EXAM. THE DRX-1 DETECTOR WAS PLACED BEHIND THE PT'S BACK WHILE THE PT WAS STILL IN THE BED. THE BATTERY, INSTALLED IN THE BACK SIDE OF THE DETECTOR, WAS POSITIONED AWAY FROM THE PT, AGAINST THE BED. THE X-RAY TECHNOLOGIST ACTIVATED THE DETECTOR BY SELECTING THE ACTIVATION "BUTTON" FOR THE DETECTOR ON THE DRX-1 SYSTEM IMAGE ACQUISITION SCREEN. BEFORE THE EXPOSURE WAS INITIATED, THE TECHNOLOGIST SAW SMOKE COMING FROM UNDER THE PT. THE TECHNOLOGIST DID NOT INITIATE THE EXPOSURE, BUT INSTEAD REMOVED THE DETECTOR FROM UNDER THE PT. THE BATTERY LEFT A ROUND, BLACK, APPROXIMATELY 1.5 CM DIAMETER BLACK SCORCH MARK ON THE SHEET UNDERNEATH THE DETECTOR. THE BLACK SCORCH MARK WAS SURROUNDED BY SOME ADDITIONAL YELLOWISH TO BROWN COLORED SCORCHING WITHIN THE OUTLINE OF THE BATTERY CELL. THERE WAS ALSO A SMALL HOLE (LESS THAN 0.5 CM) IN THE SHEET, LOCATED WITHIN THE BLACK SCORCH MARK. THERE WAS ALSO A HOLE INT EH FOAM MATTRESS UNDERNEATH THE PT, APPROXIMATELY 1 CM IN DIAMETER AND 5CM DEEP. THIS COULD HAVE BEEN CAUSED BY BATTERY VENTING AND MELTING BATTERY PLASTIC HOUSING. ONCE THE DETECTOR WAS REMOVED, IT WAS DETERMINED THAT ONE CELL OF THE FOUR-CELL LITHIUM-POLYMER DRX-1 DETECTOR BATTERY HAD OVERHEATED, PARTIALLY MELTING THE PLASTIC BATTERY CASING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARESTREAM DRX-1 SYSTEM FLAT PANEL DIGITAL IMAGER MQB CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR