BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAGEWRITER

    MDR report key: 3231165 · Received June 25, 2013

    Report

    Report Number
    3231165
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 25, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DPS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    EKG MACHINE- BATTERIES NOT DETECTED. KEEPS GOING INTO STADNBY MODE. EKG REMAINS PLUGGED IN WHEN NOT IN USE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286869 PAGEWRITER ELECTROCARDIOGRAPH DPS PHILIPS MEDICAL SYSTEMS TOUCH *

    Patients

    Seq Age Sex Outcome Treatment
    1 *