MAUDE Adverse Event Report: NATUS NEUROLOGY INCORPORATED EDX BASE UNIT

Model Number	515-015300
Medical Device Problem Codes	Fire (1245); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Part 515-015300 edx base unit - the customer reported that the base unit is not working.A capacitor blew on one of the boards and it caught fire.No injuries reported.
Additional Manufacturer Narrative
Initial report ref natus complaint# (b)(4).The technologist was completing a set of ncs tests and when the test was done, the edx base unit started generating a "clicking" sound, accompanied by two flashing indicator lights.The technologist then smelled a burning smell and saw smoke coming out of the unit.The technologist was able to shut off the machine in time and prevent the fire from escalating.Risk review: (b)(4) rev 36 emg/ iom middleton products risk assessment spreadsheet hazard id 2.2.Cause - electronic component short-circuits or malfunctions in a way which causes flame/ fire.Effect (harm) - fire smoke inhalation, second degree burns, third degree burns.Residual risk: medium.Installation date: (b)(6) september 23, 2022.The base unit is used with the nicolet edx system (s/n: (b)(6)).Further investigation to be carried out.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint#(b)(4).After the complaint was received, natus reached out to the customer asking for additional information regarding the occurrence.The customer stated the device made a noise then smoke came out of the device.They stated the device did not flame.Reviewed the device history records and no anomalies were observed.No related capas.The base unit was delivered to depot repair for evaluation.Per ebs depot repair notes, c128 on the pca/emg main (p/n: 512-410200) was shorted and smoked.Depot repair replaced the c128 in the audio speaker section and the edx base functions.Depot repair suspects customer took base apart as it's missing 2 bottom right cover screws, and 2 board screws are loose inside, and the front label is damaged.Also noted from engineering this is a 940v part so no fame would occur.Ebs shows a diagnostic code of "electronic failure.".
Event or Problem Description
Part 515-015300 edx base unit - the customer reported that the base unit is not working.A capacitor blew on one of the boards and it caught fire.No injuries reported.

• Brand Name: EDX BASE UNIT
• Common Device Name: EDX 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: 3150 pleasant view road; middleton, WI 53562
• MDR Report Key: 20410696
• Report Number: 3010611950-2024-00003
• Device Sequence Number: 9044156
• Product Code: GWJ
• UDI-Device Identifier: 00382830037433
• UDI-Public: 00382830037433
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 515-015300
• Device Catalogue Number: 515-015300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown