MAUDE Adverse Event Report: NATUS NEURO INCORPORATED EEG ELECTRODES; CLINICAL CAP, SMALL

Model Number 021133

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

Reference (b)(4).Additional information requested from customer on november 08, 2019, including level of patient involvement and return of the product.Customer provided follow up on november 11th, 2019 confirming the doctor noticed the incorrect label prior to using it.The cap was not used on any patient.Additional attempt made to have product returned on november 26, 2019.Confirmed november 29, 2019, product will be sent back to natus in (b)(6) from (b)(6).

Event Description

Electrode clinical cap is mislabeled.

• Brand Name: EEG ELECTRODES
• Type of Device: CLINICAL CAP, SMALL
• Manufacturer (Section D): NATUS NEURO INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer (Section G): NATUS NEUROLOGY INCORPORATED; 3150 pleasant view road; middleton WI 53562
• Manufacturer Contact: janessa boone ; 3150 pleasant view road; middleton, WI 53562 ; 6088298603
• MDR Report Key: 9402897
• MDR Text Key: 172908597
• Report Number: 3010611950-2019-00072
• Device Sequence Number: 1
• Product Code: GXY
• Combination Product (y/n): N
• Reporter Country Code: TS
• PMA/PMN Number: K110223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2019

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
• Device Operator: Health Professional
• Device Model Number: 021133
• Device Catalogue Number: 021133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2019
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other