BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPGRADE NEUROWORKS 9.X REVIEW SOFTWARE NON-NATUS PC

    MDR report key: 12174193 · Received July 15, 2021

    Report

    Report Number
    9612330-2021-00011
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    July 9, 2021
    Report Date
    October 8, 2021
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    GWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF NATUS COMPLAINT #(B)(4). PRODUCT EXAMINATION AND FUNCTIONAL TESTING WERE NOT PERFORMED BY NATUS BECAUSE THE CUSTOMER CONFIRMED THE CAUSE OF THE MALFUNCTIONING PART ON-SITE. RISK MANAGEMENT FILE REVIEW: THE CURRENT RISK FILE DOC-010378 - REV 46 HAZARD ID 5.6 IDENTIFIES THE ISSUE. HARM: CLINICALLY INSIGNIFICANT TO DELAYED DIAGNOSIS. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND. INVESTIGATION DETAILS AND INFORMATION ARE STILL UNDER REVIEW.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF NATUS COMPLAINT # (B)(4). SECTION D4., INCLUDED UNIQUE IDENTIFIER (UDI) (B)(4). PRODUCT EXAMINATION AND FUNCTIONAL TESTING: PRODUCT EXAMINATION AND FUNCTIONAL TESTING WERE NOT PERFORMED BY NATUS BECAUSE THE CUSTOMER CONFIRMED THE CAUSE OF THE MALFUNCTIONING PART ON-SITE. INSTALLATION DATE: (B)(6) 2020. INVESTIGATION RESULTS: (B)(4) WAS CREATED FOR ENGINEERING INVESTIGATION. ISSUE OF PCS FREEZING WAS RESOLVED INTERNALLY WHEN IT RECONFIGURED FIREWALL/PORT BLOCK SETTINGS. INVESTIGATION RESULT CODE: NEURO SBU/SYSTEM CONFIGURATION. CLOSURE RATIONALE: COMPLAINT VERIFIED, ISOLATED INCIDENT AND MONITOR FOR FUTURE OCCURRENCE. NO DEATH OR SERIOUS INJURY, CONSIDERED A CUSTOMER INCONVENIENCE. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Description of Event or Problem · 0

    UPGRADE NEUROWORKS 9.X REVIEW SOFTWARE NON-NATUS PC - A NURSE STATION FROZE AND THE PATIENT EEG WAS NO LONGER BEING MONITORED.

    Description of Event or Problem · 0

    UPGRADE NEUROWORKS 9.X REVIEW SOFTWARE NON-NATUS PC - A NURSE STATION FROZE AND THE PATIENT EEG WAS NO LONGER BEING MONITORED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT REF NATUS COMPLAINT #(B)(4). UPGRADE NEUROWORKS 9.X REVIEW SOFTWARE NON-NATUS PC - A NURSE STATION FROZE AND THE PATIENT EEG WAS NO LONGER BEING MONITORED. A NURSE STATION FROZE AND THE PATIENT EEG WAS NO LONGER BEING MONITORED. THE PATIENT HAD A SEIZURE AND TURNED BLUE. THE PATIENTS' ROOMMATE HEARD THE PATIENT GASPING FOR AIR AND PULLED HIS OWN CALL BUTTON FOR HELP. NO ALERTS TO THE NURSES, NO WAY TO MONITOR OR RESPOND. THE SYSTEM FREEZES UP BETWEEN 6A AND 6:30A , THE LOCAL SUPPORT REP CONTINUES TO ATTEMPT TO FIGURE OUT THE ISSUE. THE ISSUE HAS BEEN ONGOING FOR 1 YEAR. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 1

    UPGRADE NEUROWORKS 9.X REVIEW SOFTWARE NON-NATUS PC - A NURSE STATION FROZE AND THE PATIENT EEG WAS NO LONGER BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071654 UPGRADE NEUROWORKS 9.X REVIEW SOFTWARE NON-NATUS PC UPGRADE NEUROWORKS 9.X REVIEW SOFTWARE NON-NATUS PC GWQ NATUS MEDICAL INCORPORATED LC103-U9

    Patients

    Seq Age Sex Outcome Treatment
    1