MAUDE Adverse Event Report: NATUS MEDICLA INC. DBA EXCLE-TECH LTD (XLTEK) XLTEK NEUROWORKS; NEUROWORKS SOFTWARE

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/10/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014 we became aware of voluntary report (report #22007710000-2014-8038) submitted through fda medwatch program involving one natus electroencephalography system for long term monitoring used within an epilepsy monitoring unit at (b)(6) hospital.Reportedly the eeg technician notified that the audible alarms were not going off when she pressed the patient event button attached to the acquisition system, further analysis of the incident performed by the client corroborated that the alarm settings were modified at the nurse station monitoring system.System performed as intended however client expressed concern about the cause of the problem lying on the device instead of the staff inadvertently having changed the settings.

Manufacturer Narrative

Quality system regulations and our quality management system we initiated an evaluation of the incident as described in the medwatch report.We identified a customer complaint record that documented this incident on (b)(6) 2014 - note that according to client's medwatch report the incident occurred on (b)(6) 2014.The supporting documentation of the case contains client's statement about key settings that were purposefully modified by someone from their staff.Technical service specialist advised client to introduce user restrictions by changing the xlsecurity settings in the configuration of the nurse station, it was explained to the client that device software provides adequate authorization, access control, and accountability features that are part of the best security practices.To modify the alarm settings the user require to follow a sequence of steps that can be performed if the user deliberately intends to perform so.Based on the information we have reviewed we conclude that the device did perform as intended.

• Brand Name: XLTEK NEUROWORKS
• Type of Device: NEUROWORKS SOFTWARE
• Manufacturer (Section D): NATUS MEDICLA INC. DBA EXCLE-TECH LTD (XLTEK); 2568 bristol cir.; oakville, ontario L6H 5 S1; CA L6H 5S1
• Manufacturer Contact: sanjay mehta ; 2568 bristol cir.; oakville, ontario L5H S-S1 ; CA L5H SS1 ; 9052875055
• MDR Report Key: 4317424
• MDR Text Key: 5213469
• Report Number: 9612330-2014-00002
• Device Sequence Number: 1
• Product Code: OMB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: No
• 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