BEUDAMED
    FDA Adverse Event Other Summary report: N

    PAGEWRITER TC30 CARDIOGRAPH

    MDR report key: 1812792 · Received August 20, 2010

    Report

    Report Number
    1218950-2010-01349
    Event Type
    Other
    Date Received
    August 20, 2010
    Report Date
    July 28, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    JON
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER DISAGREED WITH A 12-LEAD ECG INTERPRETATION. THE ECG WAS REVIEWED BY THE PHILIPS' ALGORITHM TEAM. THE ALGORITHM WAS WORKING AS DESIGNED AND INTENDED. THERE WAS NO MALFUNCTION OF THE ALGORITHM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DXL ALGORITHM INTERPRETATION OF ECG IS INACCURATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAGEWRITER TC30 CARDIOGRAPH NONE JON PHILIPS HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1