BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EREADER

    MDR report key: 15325771 · Received August 31, 2022

    Report

    Report Number
    3003110749-2022-00011
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    July 21, 2020
    Report Date
    July 21, 2020
    Manufacturer
    ESCREEN, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K003352
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IN QUESTION IS A PERIPHERAL HARDWARE COMPONENT USED IN CONJUNCTION WITH OUR E-READER MEDICAL DEVICE. THERE WAS NO DEFICIENCY NOTED WITH THE E-READER UNIT THAT WAS CONNECTED TO THE POWER SUPPLY ADAPTER. THE COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THOUGH A ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED, A REVIEW OF THIS EVENT AND OTHER SIMILARLY REPORTED EVENTS FOUND THAT THE ISSUE MAY BE ATTRIBUTED TO THE MANUFACTURER OF THE POWER SUPPLY ADAPTER. THE ISSUE HAS BEEN ESCALATED FOR FURTHER REVIEW AND INVESTIGATION. E-SCREEN WILL CONTINUE TO MONITOR AND TREND THIS ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH THEIR E-READER POWER SUPPLY. REPORTEDLY, THE POWER SUPPLY WAS OVERHEATING AND CRACKING THE CASE. ADDITIONAL INFORMATION WITH REGARDS TO WHETHER ANY INJURY OCCURRED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2467910 EREADER DRUG SCREENING PLATFORM JJQ ESCREEN, INC. VERSION 3 11108

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown