BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUVEIN VEIN VISUALIZATION SYSTEM

    MDR report key: 20135324 · Received September 3, 2024

    Report

    Report Number
    MW5159189
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 20, 2024
    Report Date
    August 28, 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

    CC300 BURNED WHILE CHARGING AV500. AV500 WAS LEFT TO CHARGE IN CC300 REV 1.2 WHILE IN THE 7TH FLOOR NEUROSCIENCE DEPARTMENT AND AFTER SOME TIME, THE CLINICIANS WENT TO CHECK ON IT AND NOTICED A BURNING SMELL. THEY REMOVED THE AV500 FROM THE CC300 REV 1.2 (CC10280037) AND NOTICED BURN MARKS ON THE CC300. THE AV500 CHARGES TO SPECIFICATION, POWERS ON AND PROJECTS VEINS, AND REMAINED IN CLINICAL USE WITH NO ISSUE. NO PATIENT WAS INVOLVED, AND THE ROOM THE DEVICE WAS CHARGING IN WAS ISOLATED FROM PATIENTS, AND A LOW-TRAFFIC AREA FOR THE CLINICAL END USERS. BIOMED PROVIDED THE FOLLOWING INFORMATION VIA EMAIL: PHOTOS OF BURN, CC300 AND POWER SUPPLY PHOTOS; PERIOD OF TIME THAT THE DEVICE CHARGING; MODEL OF POWER SUPPL Y USED; VOLTAGE OUTPUT OF PS. THERE ARE NO PTS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699397 ACCUVEIN VEIN VISUALIZATION SYSTEM DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN INC. AV500 CC10280037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown