MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORATED CORKSCREW ELECTRODE 1.2M LEAD; CORK SCREW ELECTRODE

Model Number	017505
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Customer is inconsistent on reporting frequency of incident.Customer no longer has any remaining electrodes and does not wish to further pursue complaint.
Event or Problem Description
Corkscrew electrode broke during patient testing.

• Brand Name: CORKSCREW ELECTRODE 1.2M LEAD
• Common Device Name: CORK SCREW ELECTRODE
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORATED; 3150 pleasant view road; middleton WI 53562
• MDR Report Key: 7318597
• Report Number: 3010611950-2018-00002
• Device Sequence Number: 1890500
• Product Code: GXZ
• UDI-Device Identifier: 16955739010015
• UDI-Public: 16955739010015
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K072276
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/07/2018

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: Other Health Care Professional
• Device Model Number: 017505
• Device Catalogue Number: 017505
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1