MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-13 for XLTEK BRAIN MONITOR manufactured by Natus.
[45137980]
Patient Sequence No: 1, Text Type: N, H10
[45137981]
Patient was being monitored on eeg for potential seizure activity. The alarm from the eeg system did not alert as expected by clinicians. Investigative findings indicated that the software that elicits the alarm went into a pause state temporarily. The software has since been updated and according to persyst the patch should prevent a re-occurrence. Manufacturer response for eeg acquisition module, na (per site reporter): the manufacturer of the software persyst analyzed error logs and findings indicated a problem that they could not replicate in their environment. However, they have provided a patch to address the problem
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5652286 |
| MDR Report Key | 5652286 |
| Date Received | 2016-05-13 |
| Date of Report | 2016-03-29 |
| Date of Event | 2016-03-04 |
| Report Date | 2016-03-29 |
| Date Reported to FDA | 2016-03-29 |
| Date Reported to Mfgr | 2016-03-29 |
| Date Added to Maude | 2016-05-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XLTEK BRAIN MONITOR |
| Generic Name | AMPLITUDE-INTEGRATED ELECTROENCEPHALOGRAPH |
| Product Code | OMA |
| Date Received | 2016-05-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE, WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-13 |