BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAGEWRITER TOUCH CARDIOGRAPH

    MDR report key: 1511089 · Received September 28, 2009

    Report

    Report Number
    1218950-2009-01374
    Event Type
    Malfunction
    Date Received
    September 28, 2009
    Report Date
    April 1, 2009
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    PMA / PMN Number
    K020708
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER STATED THAT UNIT QTC INTERPRETATION IS INCORRECT AND THE CARDIOLOGIST FEELS IT PUTS PATIENTS AT RISK. NO ADVERSE PT IMPACT WAS REPORTED. IN 2009 THIS CUSTOMER REPORTED THAT THEY WERE UNHAPPY THAT A PROLONGED QTC WAS NOT "CALLED OUT" OR INCLUDED IN THE PRINTED 12 LEAD ECG INTERPRETATION UNDER CERTAIN CONDITIONS (I.E. LVH, ISCHEMIA). THE QTC VALUE IS GENERATED, AND THE VALUE IS RECORDED IN THE DATA SECTION, BUT MAY NOT BE CALLED OUT AS A PRINTED STATEMENT. NOTE THAT THE LABELING STATES THAT ALL 12 LEAD ECG'S MUST BE OVER-READ BY A PHYSICIAN. THERE WAS NO MALFUNCTION OF THE DEVICE. THIS IS A CUSTOMER SATISFACTION ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT UNIT QTC INTERPRETATION IS INCORRECT AND THE CARDIOLOGIST FEELS IT PUTS PATIENTS AT RISK. NO ADVERSE PATIENT IMPACT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1