BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KOS

    MDR report key: 3185619 · Received June 18, 2013

    Report

    Report Number
    1000391282-2013-00001
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 3, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MILESTONE S.R.L.
    Product Code
    IEO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A MEDICAL DEVICE, MODEL "KOS" (PROPERTY OF THE DISTRIBUTOR), WAS PRESENT IN THE FACILITY TO TEMPORARILY SUBSTITUTE THE FINAL USER'S KOS UNIT, WHICH WAS AT DISTRIBUTOR FACILITY FOR SVC REPAIR. THE SUBSTITUTING KOS WAS NOT PROPERLY CALIBRATED CAUSING THE TEMP TO EXCEED THE DESIGNED LEVEL. THIS RESULTED IN THE PARAFFIN HEATING EXCESSIVELY AND EVENTUALLY BOILING OFF. ONCE PROPERLY CALIBRATED THE KOS UNIT WORKED PROPERLY, AS DESIGNED. TISSUES (45 SPECIMENS) WERE SUB-OPTIMIZED DUE TO THE ADDITIONAL HEATING DURING PARAFFIN INFILTRATION, HOWEVER USER INDICATED THAT DIAGNOSIS WAS POSSIBLE. CUSTOMER CONFIRMED ON (B)(6) 2013 THAT SOME/ALL OF AFFECTED SPECIMENS WERE USED FOR PT DIAGNOSIS. THEREFORE WE HAVE DESIGNATED THIS EVENT AS A "PRODUCT PROBLEM" AND NOT AN "ADVERSE EVENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277436 KOS PROCESSOR, TISSUE, AUTOMATED IEO MILESTONE S.R.L. 67050

    Patients

    Seq Age Sex Outcome Treatment
    1