BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAGEWRITER TOUCH CARDIOGRAPH

    MDR report key: 909959 · Received October 8, 2004

    Report

    Report Number
    1218950-2004-00278
    Event Type
    Malfunction
    Date Received
    October 8, 2004
    Date of Event
    August 13, 2004
    Report Date
    August 18, 2004
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FACTORY HAS NOT YET REC'D THE DEVICE FOR EVAL AND THIS COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DISPLAYED INCORRECT ECG INFO FOR A PT. THERE WAS ON PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAGEWRITER TOUCH CARDIOGRAPH CARDIOGRAPH DPS PHILIPS MEDICAL SYSTEMS 860284 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA