BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESTREAM DRX-REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 3558827 · Received January 7, 2014

    Report

    Report Number
    1317307-2013-00019
    Event Type
    Injury
    Date Received
    January 7, 2014
    Date of Event
    October 1, 2013
    Report Date
    December 20, 2013
    Manufacturer
    CARESTREAM HEALTH, INC.
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT REPORT THIS ISSUE TO CARESTREAM. AS STATED ON THE FIRST PAGE OF THIS REPORT THE FE HAD THOUGHT THAT THEY HAD HEARD OF THIS ISSUE AT THIS SITE. THE SITE HAS 4 DRX-REVOLUTION MOBILE X-RAY SYSTEMS AND THE EXACT SYSTEM WHERE THIS ISSUE OCCURRED IS UNK. EACH OF THE 4 SYSTEMS HAVE UNDERGONE THE REGULARLY SCHEDULED PREVENTIVE MAINTENANCE VISITS AND THERE HAS NOT BEEN ANY REPORT OF ANY SYSTEM ISSUES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. IT IS BELIEVED THAT THIS ISSUE WAS A USER ACCIDENT.

    Description of Event or Problem · 1

    A CARESTREAM FE REPORTED THAT HE THOUGHT THAT HE HAD HEARD OF A SPECIFIC SITE WHERE A TECH HAD RUN THE EQUIPMENT OVER THEIR TOE WHICH RESULTED IN A FRACTURE. THE CUSTOMER DID NOT CALL CARESTREAM TO REPORT THIS ISSUE. IT WAS ALSO RELATED THAT THIS INCIDENT HAD OCCURRED APPROXIMATELY 1-2 MONTHS AGO, HOWEVER, THE ACTUAL DATE IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10796 CARESTREAM DRX-REVOLUTION MOBILE X-RAY SYSTEM DRX-REVOLUTION IZL CARESTREAM HEALTH, INC. 5240-9357

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention