BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE MP50

    MDR report key: 7027829 · Received November 14, 2017

    Report

    Report Number
    7027829
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    July 28, 2017
    Report Date
    September 29, 2017
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    BZQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIO MED LOG: ELECTRONIC HEALTH RECORD (EHR) NOT DOWNLOADING TO MONITOR. MONITOR TESTED, CONFIRMED DATA NOT TRANSFERRING FROM MONITOR TO EHR. PHILIPS TECH SUPPORT CALLED, PARTS ORDERED AND INSTALLED. SIX WEEKS LATER - ABOVE ISSUE STILL EXISTS. MORE TROUBLE SHOOTING WITH PHILIPS SUPPORT AND EHR IT BUT NO SOLUTION. THREE MONTHS PASSED AND ISSUE CONTINUES. NEW NETWORK CARD OBTAINED AND INSTALLED, REPLACING CARD PURCHASED 6 MONTHS PRIOR. ISSUE DID NOT RESOLVE. FINALLY AFTER 4 MONTHS, DECISION MADE TO REPLACE THE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808558 INTELLIVUE MP50 BEDSIDE PHYSIOLOGIC MODULAR MONITOR BZQ PHILIPS MEDICAL SYSTEMS M8004A

    Patients

    Seq Age Sex Outcome Treatment
    1