MAUDE Adverse Event Report: NATUS NEUROLOGY INCORPORATED EDX BASE UNIT

Model Number	515-015300
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ref natus complaint#(b)(4).The customer was shipped an exchange edx base unit, serial number (b)(6), for resolution.The customer was sent instructions for the return of the affected base unit, to natus.Risk review: (b)(4) rev 33 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 could cause death or serious injury to operator, patient or others.Residual risk: medium inherent to use of emg equipment.The hazards identified have been evaluated and found to be in compliance with a known standard.As noted in qms-001647, hazards that have been evaluated and found to be in compliance with known standards can be presumed to be consistent with an acceptable level of risk, yielding an acceptable risk / benefit to the patient or user.Risk outweighed by benefit of use of device.Further investigation to be carried out.
Event or Problem Description
Part 515-015300 edx base unit - power on system and unit sparked.The equipment started pulsing while unattended.The staff heard it and unplugged the system because it was smoking.There was also a burnt plastic like smell.The customer then re-plugged the machine, it started pulsing and smoking again.No injuries reported.
Additional Manufacturer Narrative
Follow up report 001 ref natus complaint#(b)(4).No related capas.The customer returned the affected base unit, to natus.(b)(6) 2024: per ebs depot repair notes, depot repair looked at the base unit and the gnd to +15v has a 5.8ohm short.+15 output of the power supply is shorted and burnt up.The device is currently with engineering for further investigation.
Event or Problem Description
Part 515-015300 edx base unit - power on system and unit sparked.The equipment started pulsing while unattended.The staff heard it and unplugged the system because it was smoking.There was also a burnt plastic like smell.The customer then re-plugged the machine, it started pulsing and smoking again.No injuries reported.
Event or Problem Description
Part 515-015300 edx base unit - power on system and unit sparked.The equipment started pulsing while unattended.The staff heard it and unplugged the system because it was smoking.There was also a burnt plastic like smell.The customer then re-plugged the machine, it started pulsing and smoking again.No injuries reported.
Additional Manufacturer Narrative
Follow up report 002 ref natus complaint# (b)(4).Installation date of the device: serial (b)(6) - december 19, 2023.Investigation results: power supply output is burnt up.Gnd to +15volts is a 5.8ohm short.Replaced power supply, burned-in 24hrs and edx base passed functional test.Root cause/probable root cause: suspect output cap c25 shorted and burnt up.Recommended actions: no action, this is the first time this failure has been seen.Failure confirmed: yes.Investigation result code: neuro sbu|failure electrical component.

• 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: 18746352
• Report Number: 3010611950-2024-00001
• Device Sequence Number: 3729481
• Product Code: GWJ
• UDI-Device Identifier: 00382830037433
• UDI-Public: 00382830037433
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2024

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): Initial
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 01/29/2024; Not provided
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 03/22/2024; 06/14/2024
• 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