BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESTREAM DRX REVOLUTION

    MDR report key: 2993067 · Received March 1, 2013

    Report

    Report Number
    1317307-2013-00001
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 28, 2013
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE POWER PLUG ON THE DRX REVOLUTION IS CLEAR AND THE WIRES TO THE CONNECTING CABLE ARE VISIBLE WITHIN THE PLUG. THE CARESTREAM FIELD ENGINEER INVESTIGATED THIS ISSUE AND WAS NOT ABLE TO OBSERVE THE SPARKING REPORTED BUT DID OBSERVE THE DISCOLORED WIRING IN THE PLUG WHICH WAS LIKELY CAUSED BY OVERHEATING INSIDE OF THE PLUG CASING. INTERNAL CARESTREAM INVESTIGATION REVEALED THAT THE WIRING WITHIN THE PLUG WAS EITHER LOOSE TO START OR WAS ABLE TO BECOME LOOSE AND SEPARATE FROM THE INTENDED CONNECTION. THIS SEPARATION ALLOWED FOR A CONDITION WHERE THERE COULD BE A SPARK INSIDE THE PLUG CASING. THIS SPARK WOULD RESULT IN OVERHEATING AS THE CASING IS MADE OF FLAME RETARDANT, SELF-EXTINGUISHING MATERIAL.

    Description of Event or Problem · 1

    CARESTREAM RECEIVED A REPORT OF A PLUG WHICH SPARKED AND BURNED ON A DRX REVOLUTION SYSTEM AT (B)(6) 2013. THE FIELD ENGINEER OBSERVED THAT THE WIRING INSIDE OF THE PLUG WAS DISCOLORED AND APPEARED TO HAVE OVERHEATED. ¿BURNED¿ WAS THE TERM USED BY THE CUSTOMER IN THE COMPLAINT FILE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89416 CARESTREAM DRX REVOLUTION DRX REVOLUTION IZL CARESTREAM HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1