MAUDE Adverse Event Report: NATUS NEUROLOGY INCORPORATED EDX US / CANADA + BASE UNIT

Model Number	982A0597
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4) related report #3902560000-2026-8023.Per (b)(4) rev 37 emg/ iom middleton products risk assessment spreadsheet hazard 16.4 - system becomes completely non-functional clinical use (non-or) effect (harm): delay in use of the system with no clinical effects.Residual risk: minor the hazards identified have rba rating of low 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.Further investigation to be carried out.
Event or Problem Description
Part 982a0597 - due to the emg [electromyogram] machine not connecting and turning on correctly, patients needed their emg tests rescheduled.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint# (b)(4).Related report #3902560000-2026-8023.Per (b)(4) rev 37 emg/ iom middleton products risk assessment spreadsheet hazard 16.4 - system becomes completely non-functional clinical use (non-or) effect (harm): delay in use of the system with no clinical effects.Residual risk: minor the hazards identified have rba rating of low 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.Install date: (b)(6) 2015.Per (b)(4) rev 37, the nicolet edx system is beyond its expected service life.Device is expected to be in active service usage for 7 years from the date of installation.Investigation results: the affected product was not returned.The customer was requested to provide a video of the failure to assist with the investigation.The customer confirmed the unit did not take any videos of the error.Per the customer, the unit leader stated that "the machine cannot be fixed; it was corrupted by a microsoft update.A new machine was purchased to replace the corrupted one.".
Event or Problem Description
Part 982a0597 - due to the emg [electromyogram] machine not connecting and turning on correctly, patients needed their emg tests rescheduled.

• Brand Name: EDX US / CANADA + BASE UNIT
• Common Device Name: EDX US / CANADA + BASE UNIT
• Manufacturer (Section D): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway, H91PD 92; EI H91PD92
• Manufacturer Contact: gráinne walsh ; 3150 pleasant view road; middleton 53562
• MDR Report Key: 24568361
• Report Number: 3010611950-2026-00001
• Device Sequence Number: 9500127
• Product Code: GWQ
• UDI-Device Identifier: 00382830032759
• UDI-Public: 00382830032759
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 982A0597
• Device Catalogue Number: 982A0597
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown