BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE PIIC IX

    MDR report key: 9145678 · Received October 2, 2019

    Report

    Report Number
    9145678
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    January 8, 2019
    Report Date
    May 13, 2019
    Manufacturer
    PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
    Product Code
    MSX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PATIENT MONITORING CENTRAL STATIONS DID NOT SWITCH OVER TO LOCAL MODE AS THEY SHOULD HAVE. THE CENTRALS CONTINUED REBOOTING AND TRYING TO CONNECT TO THE SERVER THAT WAS LOCKED UP. FROM THE CENTRALS, IT APPEARED THAT THE SERVERS WERE AVAILABLE BUT WOULD NOT CONNECT. CLINICIANS HAD NO CENTRAL MONITORING DURING THE DOWNTIME. THE SAME PROBLEM WAS EXPERIENCED IN ANOTHER PART OF THE HOSPITAL ON A PREVIOUS DATE. (B)(6) IS WORKING ON THE PROBLEM BUT HAS NOT PROVIDED REMEDIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940200 INTELLIVUE PIIC IX SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS MSX PHILIPS ELECTRONICS NORTH AMERICA CORPORATION INTELLIVUE PIIC IX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1