BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCREEN PRINTER

    MDR report key: 15215385 · Received August 12, 2022

    Report

    Report Number
    3003110749-2022-00005
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 14, 2022
    Report Date
    July 14, 2022
    Manufacturer
    AMEDITECH, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION IS A PERIPHERAL HARDWARE UNIT USED IN CONJUNCTION WITH OUR EREADER+ DEVICE. THERE WAS NO DEFICIENCY NOTED WITH THE EREADER+ THAT WAS CONNECTED TO THE PRINTER. INVESTIGATION OF THIS EVENT IS IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT PRODUCT WAS NOT RETURNED. THOUGH A ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, A REVIEW OF THIS EVENT AND OTHER SIMILARLY REPORTED EVENTS FOUND THAT THERE IS AN OVERHEATING ISSUE WITH THE PRINTER. THE THIRD-PARTY MANUFACTURER OF THE PRINTER HAS BEEN MADE AWARE OF THIS ISSUE FOR INVESTIGATION. ESCREEN WILL CONTINUE TO MONITOR AND TREND THIS ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR PRINTER HAD ERROR LIGHTS THAT WOULD NOT TURN OFF AND THAT IT WOULD NOT PICK UP PAPER. AS A RESULT, THE CUSTOMER WAS ADVISED TO REPLACE THE DRUM. AS THE DRUM WAS BEING REPLACED, A BURNING SMELL WAS THEN NOTED TO BE COMING FROM THE PRINTER. THE CUSTOMER SUBSEQUENTLY CONFIRMED THAT NO INJURY OCCURRED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1469367 ESCREEN PRINTER COMPUTER PRINTER LNX AMEDITECH, INC. 2070700042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Disability