BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESCREEN PRINTER

    MDR report key: 15290836 · Received August 25, 2022

    Report

    Report Number
    3003110749-2022-00006
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    July 27, 2022
    Report Date
    July 27, 2022
    Manufacturer
    AMEDITECH, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. SCREEN WILL CONTINUE TO MONITOR AND TREND THIS ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THEIR PRINTER KEEPS ASKING FOR PAPER, EVEN THOUGH THERE IS PAPER LOADED IN THE TRAY. ADDITIONALLY, THE PRINTER REPORTEDLY SMELLS LIKE IT'S ON FIRE. ADDITIONAL INFORMATION WITH REGARDS TO THE PRECISE LOCATION OF THE BURNING SMELL AND WITH REGARDS TO WHETHER ANY INJURY OCCURRED WAS REQUESTED. HOWEVER, A RESPONSE HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256805 ESCREEN PRINTER COMPUTER PRINTER LNX AMEDITECH, INC. 2070700042

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown