BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS NEUROWORKS CEEG

    MDR report key: 20891628 · Received December 10, 2024

    Report

    Report Number
    9612330-2024-00048
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    October 1, 2024
    Report Date
    March 20, 2025
    Manufacturer
    NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD.
    Product Code
    OMB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REF TO NATUS COMPLAINT # (B)(4). THE CUSTOMER HAS CONFIRMED THE AFFECTED ITEM IS PART 515-005500F, DESCRIPTION: CORTICAL STIMULATOR CONTROL UNIT-FIXED. THIS PART IS RELATED TO OUR ESTABLISHMENT: NATUS NEUROLOGY INCORPORATED, 3150 PLEASANT VIEW ROAD MIDDLETON, WI 53562. REGISTRATION NUMBER: 3010611950. REPORT 3010611950-2025-00002 WILL BE GENERATED TO CAPTURE THE FULL INVESTIGATION DETAILS FOR THIS PART.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REF TO NATUS COMPLAINT (B)(4). CORRECTED SECTION D1. AND D2A. WITH DEVICE DESCRIPTION 'NATUS NEUROWORKS CEEG' AS THIS WAS NOTED IN THE RELATED REPORT# 2200310000-2024-8002 THAT WAS SENT BY THE CUSTOMER. CORRECTED SECTION D4 FOR DEVICE INFOMATION BY REMOVING REFERENCE TO (B)(4), LOT 20813 AND UDI#(B)(4). AS THE CUSTOMER DID NOT CONFIRM THE AFFECTED ITEM INFORMATION OR RESPOND TO FOLLOW UP ATTEMPTS THAT WERE MADE. PER (B)(4). REV 79 EEG/PSG RISK ANALYSIS: HAZARD 5.6 - APPLICATION SOFTWARE (NEUROWORKS) MALFUNCTION PREVENTS DATA ACQUISITION EFFECT (HARM): DELAYED DIAGNOSIS - WITH NO CLINICAL EFFECTS. THE HAZARDS IDENTIFIED HAVE RBA RATING OF NEGLIGIBLE AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. TECHNICAL SUPPORT SENT THE ADVERSE EVENT QUESTIONNAIRE TO THE CUSTOMER AND ADDITIONAL FOLLOW UP ATTEMPTS TO OBTAIN FURTHER INFORMATION. NO FURTHER FOLLOW UP ACTION HAS BEEN RECORDED OR CROSS REFERENCED IN THIS COMPLAINT FOR AT LEAST 45 DAYS SINCE THE CUSTOMER WAS LAST ASKED TO RETURN THE AE QUESTIONNAIRE. THE CUSTOMER HAS NOT RESPONDED TO ANY ADDITIONAL ATTEMPTS OR TO CONFIRM IF THIS ISSUE IS ONGOING. REVIEW OF CUSTOMER'S ACCOUNT FOUND NO ADDITIONAL RELATED CALLS. THE AFFECTED PRODUCT WAS NOT CONFIRMED OR RETURNED. INVESTIGATION RESULT CODE: NEURO SBU/NO RESPONSE FROM CUSTOMER. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). A QUESTIONNAIRE HAS BEEN SENT TO THE CUSTOMER. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    ERROR MESSAGE REGARDING DSM CONTROL ISSUE/INTERNET DURING EMU MONITORING. PROCEDURE AT THE TIME WAS SURGICAL EEG PLACEMENT AND EMU ADMISSION.

    Description of Event or Problem · 0

    ERROR MESSAGE REGARDING DSM CONTROL ISSUE/INTERNET DURING EMU MONITORING. PROCEDURE AT THE TIME WAS SURGICAL EEG PLACEMENT AND EMU ADMISSION.

    Description of Event or Problem · 0

    ERROR MESSAGE REGARDING DSM CONTROL ISSUE/INTERNET DURING EMU MONITORING. PROCEDURE AT THE TIME WAS SURGICAL EEG PLACEMENT AND EMU ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2501757 NATUS NEUROWORKS CEEG NATUS NEUROWORKS CEEG OMB NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. LC101-9 20813

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Female