MAUDE Adverse Event Report: NATUS NEURO INCORPORATED NICONE; NIC1 C64 NOR W/ CBL HOLDER

Model Number	515-004400
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Determined probable root cause is use of c64 amplifier with inadequate grounding of the cardiac ablation system.
Event or Problem Description
Patient experienced electrode burns.

• Brand Name: NICONE
• Common Device Name: NIC1 C64 NOR W/ CBL HOLDER
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 8739235
• Report Number: 3010611950-2019-00041
• Device Sequence Number: 11135366
• Product Code: GWQ
• UDI-Device Identifier: 00382830037853
• UDI-Public: 00382830037853
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K964280
• 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
• Report Date (Section B): 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 515-004400
• Device Catalogue Number: 515-004400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/27/2019
• 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
• Patient Age: 54 YR
• Patient Weight: 61