BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM

    MDR report key: 6429873 · Received March 23, 2017

    Report

    Report Number
    1317307-2017-00002
    Event Type
    Injury
    Date Received
    March 23, 2017
    Date of Event
    February 27, 2017
    Report Date
    May 1, 2017
    Manufacturer
    CARESTREAM HEALTH
    Product Code
    IZL
    PMA / PMN Number
    K120062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CARESTREAM HEALTH WILL INVESTIGATE THIS INCIDENT AND PROVIDE A FOLLOW UP REPORT WHEN INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INCIDENT WAS NOT REPORTED TO CARESTREAM HEALTH AT THE TIME OF THE EVENT AND BECAUSE OF THAT, VALUABLE INFORMATION THAT COULD HAVE BEEN COLLECTED ABOUT THE CIRCUMSTANCES OF THE INCIDENT WAS LOST. CARESTREAM HEALTH WAS ONLY MADE AWARE OF THE INCIDENT 20 DAYS LATER BUT THE LOGS FROM THE DAY OF THE EVENT WERE NO LONGER AVAILABLE ON THE UNIT. OUR FIELD ENGINEER DID NOT FIND A MECHANICAL FAILURE THAT COULD HAVE CAUSED ERRATIC DRIVING. IN ADDITION, THIS SYSTEM WAS STILL BEING USED AFTER THE INCIDENT, WHICH SHOWS THERE WAS NOT A MECHANICAL FAILURE OF THE SYSTEM. THE INITIAL INTERVIEW WITH THE SITE INDICATED THAT THE PERSON INJURED WAS USING THE SYSTEM IN A NON-STANDARD WAY BUT WE HAVE NOT BEEN ABLE TO CONFIRM THIS DUE TO THE ABSENCE OF LOGS. THEREFORE THE ROOT CAUSE COULD NOT BE ESTABLISHED. NO FURTHER UPDATES WILL BE SENT, WE WILL CONTINUE TO MONITOR AS PART OF OUR POST-MARKET SURVEILLANCE PROCESS.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THAT DUE TO CONTACT WITH THE CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM, THE USER SUSTAINED A FRACTURED ARM.

    Description of Event or Problem · 1

    CUSTOMER ALLEGES THAT DUE TO CONTACT WITH THE CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM, THE USER SUSTAINED A FRACTURED ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211435 CARESTREAM DRX REVOLUTION MOBILE X-RAY SYSTEM DRX REVO IZL CARESTREAM HEALTH

    Patients

    Seq Age Sex Outcome Treatment
    1 Other