BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU VEIN

    MDR report key: 9382869 · Received November 27, 2019

    Report

    Report Number
    9382869
    Event Type
    Malfunction
    Date Received
    November 27, 2019
    Date of Event
    November 11, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ACCUVEIN INC.
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NO PATIENT HARM. NO PATIENT INCIDENT. POOR DESIGN. POOR SERVICEABILITY. HAND HELD ACCUVEIN DEVICE WAS PUT INTO SERVICE AND FAILED THREE MONTHS LATER DUE TO A BAD BATTERY. AFTER SPEAKING WITH THE COMPANY, THEY SAID WE NEEDED TO SEND THE DEVICE IN FOR REPAIR. THERE IS ALSO A SAFETY/SECURITY SCREW ON THE DEVICE THAT MAKES IT MORE DIFFICULT TO REPLACE THE BATTERY. THE BATTERY IS PROPRIETARY WHICH FURTHER MAKES IT DIFFICULT TO REPAIR THE DEVICE. THESE ISSUES LEAD TO EXTENDED DOWNTIME AND THEREFORE UNAVAILABLE FOR PATIENT USE - WHICH COULD AFFECT CLINICAL WORKFLOW. MANUFACTURER RESPONSE FOR VEIN FINDER, ACCUVEIN (PER SITE REPORTER). SENDING DEVICE TODAY (DAY OF REPORT). MORE INFORMATION TO COME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1177724 ACCU VEIN DEVICE, VEIN LOCATION, LIQUID CRYSTAL KZA ACCUVEIN INC. AV500

    Patients

    Seq Age Sex Outcome Treatment
    1