MAUDE Adverse Event Report: NATUS NEUROLOGY, INCORPORATED ENDEAVOR CR DESKTOP IOM SYSTEM; MULTI-MODALITY MONITORING SYSTEM

Model Number 982A0431

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

Event Date 12/05/2014

Event Type  Injury  

Event Description

A customer complaint was reported through the natus neurology (b)(4) distributor.An (b)(6) customer was using a natus endeavor cr desktop system on a patient to monitor eeg/emg functions.The customer was performing patient stimulation in a non-recurrent mode and reported that a double stimulation occurred on the patient using a computer mouse and by clicking on the associated system computer icon.After purposely performing the first stimulation, a second stimulation pulse occurred supposedly without further input from the doctor.Following the second stimulation, the patient experienced a seizure which required drug intervention to control.

Manufacturer Narrative

Registered internally as a complaint (reference (b)(4)) for further investigation by manufacturer.The system manufacturing records were reviewed.All system component inspection tests were in specification and no issues associated with the product manufacturer were identified that may have contributed to the complaints claim.Evaluation performed by the manufacturer using duplicate equipment could not reproduce the reported multiple stimulation fault except through repeated activation of the mouse/icon interface, an expected function.The system software code was also reviewed confirming that a double stimulation cannot occur on its own.Even if this purposely occurs through repeated activation, stimulation of this kind using such equipment is not considered hazardous, is not considered adequate to initiate a patient seizure, nor is such a response reported in literature as a potential risk in electro-diagnostic medicine.

• Brand Name: ENDEAVOR CR DESKTOP IOM SYSTEM
• Type of Device: MULTI-MODALITY MONITORING SYSTEM
• Manufacturer (Section D): NATUS NEUROLOGY, INCORPORATED; 3150 pleasant view rd.; middleton WI 53562
• Manufacturer Contact: randall moog ; 3150 pleasant view rd.; middleton, WI 53562 ; 6088298802
• MDR Report Key: 4364218
• MDR Text Key: 5232280
• Report Number: 3008289288-2014-00006
• Device Sequence Number: 1
• Product Code: GWQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K991054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 982A0431
• Device Catalogue Number: 982A0431
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other