BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUVEIN POWERED WHEELED STAND

    MDR report key: 19018825 · Received April 1, 2024

    Report

    Report Number
    MW5153452
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    February 27, 2024
    Report Date
    March 29, 2024
    Manufacturer
    ACCUVEIN INC.
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    003
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024, (B)(6), A BIOMEDICAL ENGINEER WITH (B)(6) MEDICAL CENTER, (B)(6), US, REPORTED A DEVICE MALFUNCTION PERTAINING TO THE ACCUVEIN HF580 POWERED WHEELED STAND. CHARGING PINS BURNED; NO ONE WAS HARMED; AV500 CHARGES ON A DIFFERENT HF580 WITH NO ISSUE. BIOMED NOT SURE HOW OR WHEN THE CHARGING PINS WERE BURNED. HE NOTICED THE SMELL INVESTIGATED THE HF580 AND SAW THE BURNED PIN BOARD. NO PATIENTS WERE INVOLVED OR REPORTED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1624012 ACCUVEIN POWERED WHEELED STAND DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN INC. HF580 830-00083

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown