BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAIN FINDER

    MDR report key: 17836565 · Received September 27, 2023

    Report

    Report Number
    MW5146261
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Report Date
    September 25, 2023
    Manufacturer
    ACCUVEIN LLC INC.
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ACCUVEIN VEIN FINDER (MODEL AV500) DEVICES DESCRIBE BY OEM AS BACKWARDS COMPATIBLE WITH OLDER MODEL CHARGERS (300 SERIES), DESPITE OLDER CHARGERS RUNNING TWICE THE VOLTAGE AND REPEATED OUTAGES OF DEVICES USED WITH OLDER CHARGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003567 VAIN FINDER DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN LLC INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown