BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIVUE INFORMATION CENTER IX

    MDR report key: 10310452 · Received July 22, 2020

    Report

    Report Number
    1218950-2020-04262
    Event Type
    Malfunction
    Date Received
    July 22, 2020
    Report Date
    July 1, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K102495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT EVALUATION: A PHILIPS RESPONSE CENTER ENGINEER (RCE) WAS PROVIDED TWO RECORDINGS; ONE IS BEFORE THE NETWORK SWITCH CHANGE AND THE SECOND AFTERWARD. NO ERRORS REGARDING THE MULICAST GROUP COMMUNICATION COULD BE FOUND IN THE RECORDING BY THE RCE. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION ASSOCIATED WITH THIS COMPLAINT EVALUATION. CUSTOMER RESOLUTION AND CONCLUSION: THE REPORTED ISSUE COULD NOT BE CONFIRMED, HOWEVER, PHILIPS COULD NOT RULE OUT A MALFUNCTION. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING CUSTOMER RESOLUTION ASSOCIATED WITH THIS COMPLAINT, BUT ATTEMPTS HAVE BEEN UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS LATER OBTAINED, THE COMPLAINT WILL BE REOPENED. SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, DISTRIBUTOR, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BED TO BED OVERVIEW WAS NOT WORKING AFTER THEY HAD RESOLVED THEIR NETWORK ISSUES. THE DEVICE WAS NOT IN USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775939 INTELLIVUE INFORMATION CENTER IX CENTRAL STATION MONITOR MHX PHILIPS MEDICAL SYSTEMS 866389 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1