MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-11-20 for XLTEK NEUROWORKS NA manufactured by Natus Medicla Inc. Dba Excle-tech Ltd (xltek).
[5213469]
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.
Patient Sequence No: 1, Text Type: D, B5
[12765834]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612330-2014-00002 |
| MDR Report Key | 4317424 |
| Report Source | 06 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-11-18 |
| Date of Event | 2014-08-10 |
| Date Mfgr Received | 2014-10-21 |
| Date Added to Maude | 2015-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANJAY MEHTA |
| Manufacturer Street | 2568 BRISTOL CIR. |
| Manufacturer City | OAKVILLE, ONTARIO L5H SS1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L5H SS1 |
| Manufacturer Phone | 9052875055 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XLTEK NEUROWORKS |
| Generic Name | NEUROWORKS SOFTWARE |
| Product Code | OMB |
| Date Received | 2014-11-20 |
| Catalog Number | NA |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICLA INC. DBA EXCLE-TECH LTD (XLTEK) |
| Manufacturer Address | 2568 BRISTOL CIR. OAKVILLE, ONTARIO L6H5S1 CA L6H 5S1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-20 |