BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAGEWRITER TOUCH CARDIOGRAPH

    MDR report key: 6230417 · Received January 6, 2017

    Report

    Report Number
    1218950-2017-00068
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    December 1, 2016
    Report Date
    December 8, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    PMA / PMN Number
    K020708
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. THE CUSTOMER HAS NOT ALLEGED A PRODUCT FAILURE BUT IS REQUESTING TECHNICAL SUPPORT WITH INTERPRETATION OF A PATIENTS QTC DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11478 PAGEWRITER TOUCH CARDIOGRAPH PAGEWRITER TC70 CARDIOGRAPH DPS PHILIPS MEDICAL SYSTEMS 860315

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O