MAUDE Adverse Event Report: NATUS NEUROLOGY INCORPORATED NICOLETONE EEG V32 AMPLIFIER

Model Number	515-019000F
Medical Device Problem Codes	Unable to Obtain Readings (1516); Failure to Sense (1559)
Health Effect - Clinical Code	Misdiagnosis (2159)
Date of Event	01/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The system was removed from service and the amplifier was returned to natus for evaluation.The evaluation found no problems with the amplifier.A natus field service technician is going on site to evaluate the system.
Event or Problem Description
Eeg brain test; waves appeared flat, in reality they were not flat.
Additional Manufacturer Narrative
Follow up report for 3010611950-2018-00001.Reference (b)(4) for complaint, (b)(4) for onsite information.Mdr follow up: field service went on site and evaluated the system and found that the headbox had intermittent inputs.The headbox was replaced.A clinical representative reviewed the onsite information and stated that in these types of situations, eeg is not the only factor considered.Many other tests would be conducted including a thorough neuro exam.
Event or Problem Description
Eeg brain test; waves appeared flat, in reality they were not flat.

• Brand Name: NICOLETONE EEG V32 AMPLIFIER
• Common Device Name: NICOLETONE
• Manufacturer (Section D): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 7322136
• Report Number: 3010611950-2018-00001
• Device Sequence Number: 104614
• Product Code: GWQ
• UDI-Device Identifier: 00382830037167
• UDI-Public: 00382830037167
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061908
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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: 515-019000F
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/17/2018
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other