BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUVEIN

    MDR report key: 7230566 · Received January 30, 2018

    Report

    Report Number
    MW5074984
    Event Type
    Malfunction
    Date Received
    January 30, 2018
    Report Date
    January 29, 2018
    Manufacturer
    ACCUVEIN
    Product Code
    KZA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE ACCUVEIN HF470 HANDS-FREE ROLLING STAND FOR THE ACCUVEIN AV400 REGULARLY BREAKS AT THE PROXIMAL END OF THE EXTENSION ARM. THE ARM COMPLETELY BREAKS OFF THE STAND. THE BREAKS OCCUR IN USE AND DURING TRANSPORT. WE BELIEVE ONE OF THE FACTORS TO THE BREAKS IS THAT THE END USER HAS TO APPLY REGULAR DOWNWARD FORCE TO LOCK THE ARM IN AN ARM-LOCK MECHANISM THAT IS LOCATED CLOSE TO THE BREAK. THIS REGULAR STRESS CAUSES A SMALL CRACK TO APPEAR WITH REGULAR USE, WHICH THEN GROWS, AND EVENTUALLY RESULTS IN A COMPLETE BREAK. SOMETIMES THE BREAK OCCURS INTERNALLY WITHOUT THE ARM BREAKING COMPLETELY OFF, WHICH DAMAGES A POWER CORD AND PREVENTS THE AV400 FROM CHARGING WHILE IN THE STAND. UNFORTUNATELY, WE DO NOT HAVE GOOD SOLID NUMBERS ON THE NUMBER OF BROKEN STANDS B/C WE DO NOT TRACK THESE STANDS THE SAME WAY AS THE MEDICAL DEVICE THAT ATTACHES TO THE STAND. WE KNOW HOW MANY AV400S WE HAVE, BUT NOT EXACTLY HOW MANY STANDS (THEY DON'T ALL HAVE STANDS). HOWEVER, OUT OF THE 20-30 STANDS WE HAVE IN PLACE, WE BELIEVE ROUGHLY 10 HAVE BROKEN IN THE PAST 2 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72628 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72629 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72630 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72631 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72632 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72633 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72634 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72635 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72636 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470
    72637 ACCUVEIN ACCUVEIN KZA ACCUVEIN HF470

    Patients

    Seq Age Sex Outcome Treatment
    1