BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLDM, DIGITAL TOWER

    MDR report key: 2853194 · Received June 26, 2008

    Report

    Report Number
    1225671-2008-00002
    Event Type
    Malfunction
    Date Received
    June 26, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ICAD INC.
    Product Code
    LMA
    PMA / PMN Number
    P0110038
    Removal / Correction Number
    Z-1546-2008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ICAD RECEIVED INFORMATION FROM THE CUSTOMER INDICATING THAT HOLOGIC HAD IDENTIFIED THAT THE PROBLEM WAS BEING CAUSED BY THEIR DEVICE. ICAD CONTACTED HOLOGIC FOR MORE INFORMATION ON THIS ISSUE. OUR INVESTIGATION HAS IDENTIFIED THE ROOT CAUSE OF THE REPORTED CONDITION AS A SOFTWARE ERROR USED IN THE HOLOGIC WORKSTATION THAT RESULTED IN THE SKEWED CAD MARKS THAT OUR CUSTOMER REPORTED TO ICAD. ON (B)(4), 2008, ICAD BECAME AWARE OF A CLASS 3 RECALL ON THE HOLOGIC FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM. THIS SYSTEM WAS IDENTIFIED BY OUR CUSTOMER AS BEING USED WITH THE ICAD SECONDLOOK DIGITAL SERVER IN THE (B)(4) 2008 REPORTED EVENT. ICAD CONTACTED HOLOGIC TO DETERMINE IF THE CORRECTIVE ACTIONS IDENTIFIED IN THE HOLOGIC RECALL NOTIFICATION HAD TAKEN PLACE. THE HOLOGIC REPRESENTATIVE INDICATED THAT THE WORKSTATION SERIAL NUMBERS LISTED ON THE RECALL WERE BEING CORRECTED. ICAD MADE A FOLLOW-UP PHONE CALL TO OUR CUSTOMER TO CHECK THE STATUS OF THE HOLOGIC RECALL ACTIONS. OUR CUSTOMER REPORTED THAT AFTER HOLOGIC CORRECTED THE REPORTED SOFTWARE ISSUE, THE PROBLEM HAD NOT REOCCURRED. NO ADDITIONAL ACTIONS ARE PLANNED BY ICAD HOWEVER, WE WILL CONTINUE TO MONITOR FOR THE REPORTED CONDITION.

    Description of Event or Problem · 1

    WE RECEIVED NOTIFICATION FROM OUR CUSTOMER THAT OUR SECONDLOOK, COMPUTER-AIDED DETECTION (CAD) SYSTEM FOR MAMMOGRAPHY HAD ALLEGEDLY MALFUNCTIONED. THE CUSTOMER REPORTED THAT THE ICAD SYSTEM IMAGES WERE BEING SENT TO A HOLOGIC WORKSTATION THAT APPEARED SLIGHTLY SKEWED IN THE STRUCTURED WORKSTATION REPORT. THE CUSTOMER INDICATED THAT THIS EVENT OCCURRED AFTER HOLOGIC UPGRADED THEIR WORKSTATION SOFTWARE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLDM, DIGITAL TOWER SECONDLOOK DIGITAL CAD SYSTEM LMA ICAD INC. DSC002-03 NA

    Patients

    Seq Age Sex Outcome Treatment
    1