BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANSPACH CONSOLE - 200419

    MDR report key: 9989190 · Received April 23, 2020

    Report

    Report Number
    3010266064-2020-00348
    Event Type
    Malfunction
    Date Received
    April 23, 2020
    Date of Event
    December 5, 2016
    Report Date
    August 31, 2020
    Manufacturer
    BLUE BELT TECHNOLOGIES
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE DEVICE, INTENDED FOR USE IN TREATMENT, WAS NOT MADE AVAILABLE TO THE DESIGNATED COMPLAINT UNIT FOR EVALUATION. THUS, VISUAL AND FUNCTIONAL INSPECTION COULD NOT BE PERFORMED. HOWEVER, IT WAS NOTED THAT THE PART THAT WAS REPORTED TO BE BROKEN IS ACTUALLY A REMOVABLE PART. THEREFORE, THIS WAS AN EXPECTED BEHAVIOR. THE ANSPACH CONSOLE SERIAL NUMBER WAS NOT PROVIDED, THUS DHR REVIEW COULD NOT BE PERFORMED TO CONFIRM IF THE DEVICE MET MANUFACTURING SPECIFICATIONS. A COMPLAINT HISTORY REVIEW DID NOT IDENTIFY ANY SIMILAR REPORTS, THIS ISSUE WILL CONTINUE TO BE MONITORED. THE PROBABLE CAUSE OF THE ISSUE WAS THAT THE DEVICE PERFORMED WITHIN EXPECTED PARAMETERS. A RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT COULD BE ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DEMO, IT WAS NOTICED THAT THE IRRIGATION PUMP WAS BROKEN, HAS MISSING BLACK COVER AND WILL NOT CLOSE TIGHTLY OVER TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454502 ANSPACH CONSOLE - 200419 DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) HBE BLUE BELT TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1