BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAGEWRITER TOUCH CARDIOGRAPH

    MDR report key: 1484531 · Received July 30, 2009

    Report

    Report Number
    1218950-2009-00929
    Event Type
    Malfunction
    Date Received
    July 30, 2009
    Report Date
    June 30, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    PMA / PMN Number
    K020708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TC70 AND OTHER CARDIOGRAPHS RELATED TO THE QTC MEASUREMENT. THE FACTORY HAS NOT YET RECEIVED THE DEVICE FOR EVALUATION, AND THE COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DISCREPANCY BETWEEN THE TC70 AND OTHER CARDIOGRAPHS RELATED TO THE QTC MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAGEWRITER TOUCH CARDIOGRAPH DPS PHILIPS MEDICAL SYSTEMS 860315

    Patients

    Seq Age Sex Outcome Treatment
    1