BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 10148184 · Received June 12, 2020

    Report

    Report Number
    9615916-2020-00003
    Event Type
    Malfunction
    Date Received
    June 12, 2020
    Date of Event
    May 25, 2020
    Report Date
    June 11, 2020
    Manufacturer
    INTELERAD MEDICAL SYSTEMS
    Product Code
    LLZ
    UDI-DI
    B228INTELEPACS0
    PMA / PMN Number
    K150707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    A HAZARD MAY ARISE WHEN NON-DICOM COMPLIANT JPEG-2000-COMPRESSED IMAGES ARE RECEIVED BY THE (B)(6) COMPONENT WITH DICOM BIT DEPTH (BITS STORED TAG) THAT DOES NOT MATCH THE BIT DEPTH IN THE PIXEL DATA CODESTREAM. THESE IMAGES ARE DECOMPRESSED WITH A LOSS OF PRECISION IN THE IMAGE DATA WHICH CAN LEAD TO FAILING IMAGE REGISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612793 INTELEPACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ INTELERAD MEDICAL SYSTEMS INTELEPACS INTELEVIEWER 4-10-1 AND UP B228INTELEPACS0

    Patients

    Seq Age Sex Outcome Treatment
    1