BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIKANG HBG01

    MDR report key: 10534442 · Received September 15, 2020

    Report

    Report Number
    10534442
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    September 3, 2020
    Report Date
    September 11, 2020
    Manufacturer
    HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD
    Product Code
    PXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE HOSPITAL IN PART OF ITS COVID SCREENING PROCESS HAD PURCHASED A NUMBER OF ELECTRONIC INFRARED SKIN THERMOMETERS. THE PURPOSE OF THESE SKIN THERMOMETERS WERE TO PROVIDE A 1ST LEVEL OF TEMPERATURE SCREENING OF STAFF AND VISITORS. SINCE THESE HAVE BEEN PURCHASED, THERE HAS BEEN MANY REPAIRS PERFORMED ON THESE DEVICES INCLUDING BROKEN TRIGGERS, TAKING A LOW TEMP, AND NOT READING ACCURATELY. WITH THIS BEING A CRITICAL SCANNING TOOL/PROCESS THERE IS A RISK POTENTIAL IN FAILING TO PROPERLY SCREEN STAFF AND VISITORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997857 DIKANG HBG01 THERMOMETER KIT PXH HUNAN HONGGAO ELECTRONIC TECHNOLOGY CO., LTD HGB01

    Patients

    Seq Age Sex Outcome Treatment
    1