BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EREADER

    MDR report key: 15325740 · Received August 31, 2022

    Report

    Report Number
    3003110749-2022-00009
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    May 17, 2021
    Report Date
    May 17, 2021
    Manufacturer
    ESCREEN, INC.
    Product Code
    JJQ
    PMA / PMN Number
    K003352
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 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 THERE WAS A BUZZING SOUND COMING FROM THEIR EREADER DEVICE. THE BLACK BOX AND CORD OF THE POWER SUPPLY WERE NOTED TO BE VERY HOT. ADDITIONAL INFORMATION WITH REGARDS TO WHETHER ANY INJURY OCCURRED WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2088434 EREADER DRUG SCREENING PLATFORM JJQ ESCREEN, INC. VERSION 3 13835

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown