BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0

    MDR report key: 10755756 · Received October 29, 2020

    Report

    Report Number
    1218950-2020-06506
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Report Date
    August 5, 2020
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DXJ
    UDI-DI
    00884838075153
    PMA / PMN Number
    K100272
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ANESTHESIA LOG CANNOT BE DETECTED. 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
    1224740 INTELLISPACE CRITICAL CARE & ANESTHESIA REV G.0 CLINICAL INFORMATION MANAGEMENT SYSTEM DXJ PHILIPS MEDICAL SYSTEMS 866148 00884838075153

    Patients

    Seq Age Sex Outcome Treatment
    1