BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EREADER

    MDR report key: 14032618 · Received April 6, 2022

    Report

    Report Number
    3003110749-2022-00003
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Report Date
    April 6, 2022
    Manufacturer
    ESCREEN, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K003352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    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

    A CUSTOMER REPORTED EXPERIENCING A NUMBER ISSUES WITH THEIR EREADER, INCLUDING THAT THE POWER SUPPLY FOR THE DEVICE WAS MAKING A BUZZING NOISE. THE CUSTOMER ALSO SUSPECTED A SHORT IN THE WIRE OF THE POWER SUPPLY, WHICH WAS DISCARDED. 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
    918566 EREADER DRUG SCREENING PLATFORM JJQ ESCREEN, INC. VERSION 3

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown