BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTISAN LINK PRO

    MDR report key: 11031723 · Received December 17, 2020

    Report

    Report Number
    9610099-2020-00056
    Event Type
    Malfunction
    Date Received
    December 17, 2020
    Date of Event
    November 20, 2020
    Report Date
    December 17, 2020
    Manufacturer
    AGILENT TECHNOLOGIES DENMARK APS
    Product Code
    KPA
    UDI-DI
    05700571108451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ROOT CAUSE: POTENTIAL ALTERATION OF STAINING IN THIS CASE WAS DUE TO IMPROPER OPERATION OF THE HEATER ON THE SLIDE CAROUSEL. THE PROBLEM WAS SOLVED BY FIELD SERVICE ENGINEER WITH REPLACEMENT OF THE PART. FOLLOWING THE REPLACEMENT, THE INSTRUMENT WAS FULLY OPERATIONAL WITHIN SPECIFICATIONS, WITHOUT ERRORS AND AVAILABLE FOR THE USER. FAILURE MODE DESCRIPTION: FOLLOWING A HEATER MALFUNCTION OR IF THE PART STOPS WORKING; THE RESULTING FAILURE MODES DESCRIBED COULD OCCUR:, HEATER CABLE MALFUNCTION AND TEMPERATURE MISALIGNMENT. FAILURE MODE IN ALL SCENARIOS HAS THE POTENTIAL TO CAUSE A STAINING ALTERATION.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINT RECORD REPORTED THE EVENT AS FOLLOWS: HEATER FAILURE ON 6 POSITIONS. NO DIRECT OR INDIRECT PATIENT HARM OR USER HARM HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492416 ARTISAN LINK PRO ARTISAN LINK PRO KPA AGILENT TECHNOLOGIES DENMARK APS AR310 05700571108451

    Patients

    Seq Age Sex Outcome Treatment
    1