BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUVEIN AV400

    MDR report key: 10534331 · Received September 15, 2020

    Report

    Report Number
    10534331
    Event Type
    Malfunction
    Date Received
    September 15, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 11, 2020
    Manufacturer
    ACCUVEIN INC.
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    OUR HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) RECEIVED A SERVICE CALL TO INSPECT A BROKEN ACCUVEIN FINDER. THE COMPLAINT WAS THE "ARM IS SNAPPED OFF THE MACHINE, WAND IS WORKING". TECHNICIAN INSPECTED THE DEVICE AND ORDERED A REPLACEMENT ARM. ONCE RECEIVED, THE ARM WAS REPLACED AND DEVICE WAS RETURNED TO SERVICE. THIS TYPE OF REPAIR HAS HAPPENED NUMEROUS OCCASIONS AND COULD POTENTIALLY HARM THE HEALTH CARE STAFF MEMBER. MANUFACTURER WAS MADE AWARE WHEN REPLACEMENT ARM WAS SENT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997766 ACCUVEIN AV400 DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN INC. AV400

    Patients

    Seq Age Sex Outcome Treatment
    1