BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EREADER+ HOST PC

    MDR report key: 15318517 · Received August 30, 2022

    Report

    Report Number
    3003110749-2022-00007
    Event Type
    Malfunction
    Date Received
    August 30, 2022
    Date of Event
    August 2, 2022
    Report Date
    August 2, 2022
    Manufacturer
    AMEDITECH, INC.
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 COMPUTER. 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. THE THIRD-PARTY MANUFACTURER OF THE COMPUTER HAS BEEN MADE AWARE OF THIS POWER SUPPLY ISSUE FOR INVESTIGATION. A MEDITECH WILL CONTINUE TO MONITOR AND TREND THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THEIR EREADER COMPUTER HAD A BLACK SCREEN. DISCONNECTING AND RECONNECTING THE SYSTEM, AS ADVISED BY THE TECHNICAL SERVICES GROUP, WAS UNSUCCESSFUL IN RESOLVING THE PROBLEM. DURING THIS TROUBLESHOOTING SESSION, IT WAS DISCOVERED THAT THE POWER SUPPLY WIRES WERE EXTREMELY HOT. THE CUSTOMER THEN NOTED THAT THEIR UNIT HAD COMPLETELY DIED. UPON FOLLOWING UP FOR ADDITIONAL INFORMATION, IT WAS CONFIRMED THAT THERE WERE NO INJURIES THAT RESULTED FROM THE OVERHEATING WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332337 EREADER+ HOST PC COMPUTER LNX AMEDITECH, INC. M720Q

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown