BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0

    MDR report key: 10648849 · Received October 8, 2020

    Report

    Report Number
    1218950-2020-05964
    Event Type
    Malfunction
    Date Received
    October 8, 2020
    Report Date
    September 30, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXJ
    UDI-DI
    00884838075153
    PMA / PMN Number
    K100272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE NO ERRORS OR MESSAGES STORED IN THE ICCA EVENT LOGS SINCE THE ICCA SYSTEM WILL OVERWRITE STORED EVENT LOGS AFTER 24 HOURS. THE CUSTOMER WAS INFORMED AND WAS ADVISED TO CONTACT PHILIPS IMMEDIATELY IF THERE WAS A RECURRENCE OF THE PROBLEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DRUGS DISAPPEARED FROM THE MAR AFTER PLACING THE ORDERS AND THEN REAPPEARED AS "PENDING" ORDERS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118357 INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 CLINICAL INFORMATION MANAGEMENT SYSTEM DXJ PHILIPS MEDICAL SYSTEMS 866148 00884838075153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other