BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAGEWRITER

    MDR report key: 2992224 · Received February 28, 2013

    Report

    Report Number
    2992224
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 28, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEW EKG'S BEGAN TO NOT CONNCET WIRELESSLY TO THE SYSTEM TO DOWNLOAD EKG'S. SYSTEM CHECKED, FUNCTIONAL. TWO MACHINES FOUND TO HAVE BAD COMPACT FLASH CARDS. CONTINUING TO WORK WITH PHILIPS TO FIND PROBLEM AND GET ISSUES RESOLVED.======================MANUFACTURER RESPONSE FOR EKG MACHINE, TC 50 (PER SITE REPORTER).======================THEY ARE TRYING TO TROUBLESHOOT. BAD FLASH CARD.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?EKG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86041 PAGEWRITER ELECTROCARDIOGRAPH DRG PHILIPS MEDICAL SYSTEMS TC50 *
    86042 TC50 ELECTROCARDIOGRAPH DPS PHILIPS MEDICAL SYSTEMS TC 50 *
    86043 TC50 ELECTROCARDIOGRAPH DPS PHILIPS MEDICAL SYSTEMS TC 50 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *