MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORATED ELITE PROBE; ELITE 3MHZ PROBE

Model Number	X1L001
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Based on risk assessment conducted may 25, 2017, it was determined that there is a risk of injury if the malfunction were to recur.There have been no reported injuries.Reference field corrective action number: 3010611950/06/09/2017/001-r.
Event or Problem Description
Excessive static noise observed in elite probe.

• Brand Name: ELITE PROBE
• Common Device Name: ELITE 3MHZ PROBE
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 6656758
• Report Number: 3010611950-2017-00026
• Device Sequence Number: 1157276
• Product Code: JAF
• UDI-Device Identifier: 00382830028233
• UDI-Public: 00382830028233
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K982635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

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: X1L001
• Device Catalogue Number: N300
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/21/2017
• 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