BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EREADER

    MDR report key: 14852245 · Received June 29, 2022

    Report

    Report Number
    3003110749-2022-00004
    Event Type
    Malfunction
    Date Received
    June 29, 2022
    Report Date
    June 24, 2022
    Manufacturer
    ESCREEN, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K003352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 MEDICAL DEVICE. THERE WAS NO DEFICIENCY NOTED WITH THE EREADER 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. ESCREEN WILL CONTINUE TO MONITOR AND TREND THIS ISSUE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE CORD FOR THEIR EREADER POWER SUPPLY WAS MAKING A HUMMING SOUND, FOLLOWED BY A LOUD POP, AND WAS NO LONGER FUNCTIONING. THE CUSTOMER WAS ABLE TO RESTORE FUNCTIONALITY FOR THEIR EREADER SYSTEM AFTER RECEIVING A REPLACEMENT POWER ADAPTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750845 EREADER DRUG SCREENING PLATFORM JJQ ESCREEN, INC. VERSION 3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown