BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE

    MDR report key: 5207092 · Received November 6, 2015

    Report

    Report Number
    5207092
    Event Type
    Malfunction
    Date Received
    November 6, 2015
    Date of Event
    September 5, 2015
    Report Date
    September 23, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MSX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PHILIPS PATIENT MONITORING SURVEILLANCE STATION RESTARTED RESULTING IN AN OUTAGE OF SURVEILLANCE MONITORING. THIS OCCURRED DUE TO AN ATTEMPT TO RETRIEVE A DISCHARGED PATIENT THAT HAD BEEN ADMITTED MULTIPLE TIMES, MANUALLY, WITHOUT AN MRN (MEDICAL RECORD NUMBER). THE OUTAGE LASTED FOR 5 MINUTES, A DURATION FOR WHICH NO CRITICAL ALARMS WERE AUDIBLE. THE ROOT CAUSE OF THIS ISSUE WAS FOUND TO RESULT FROM A PATIENT DATABASE MIGRATION FROM PIIC IX A.02 TO PIIC IX B.01, DURING WHICH TWO FIELDS IN THE PATIENT RECORD THAT ARE NEW TO PIIC IX B.01 WERE LEFT BLANK. RETRIEVING ONE OF THESE PATIENTS USING THE PATIENT (B)(6) SEARCH APPLICATION RESULTED IN A SOFTWARE EXCEPTION ON THE SURVEILLANCE STATION, CAUSING AN APPLICATION RESTART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737281 INTELLIVUE SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS MSX PHILIPS MEDICAL SYSTEMS PIIC IX

    Patients

    Seq Age Sex Outcome Treatment
    1