MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-31 for NEUROCOM EQUITEST NCM-SMEQ manufactured by Natus Medical Incorporated.
[115650136]
Natus technical service confirmed that the system was frozen while troubleshooting the issue remotely with the complainant. Natus technical service walked the complainant through turning off the dynamic platform and disconnecting power to the computer. After letting the system rest for at least a minute, power was reconnected. The system then operated correctly and the failure could no longer be duplicated. Natus technical service advised the complainant to continue monitoring the system and contact natus should the issue reoccur. Because the issue resolved itself after cycling power to the system, the cause of the issue could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[115650137]
It was reported to natus that during a gaze stabilization test (gst), the smart equitest system froze. There was no report of death, serious injury, or environmental/safety concerns.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00135 |
| MDR Report Key | 7737403 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-31 |
| Date of Report | 2018-07-02 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-07-02 |
| Date Added to Maude | 2018-07-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES FITZGERALD |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal | 98108 |
| Manufacturer Phone | 2062685173 |
| Manufacturer G1 | NATUS MEDICAL INCORPORATED |
| Manufacturer Street | 5900 FIRST AVENUE SOUTH |
| Manufacturer City | SEATTLE WA 98108 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98108 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEUROCOM EQUITEST |
| Generic Name | SMART EQUITEST |
| Product Code | KHX |
| Date Received | 2018-07-31 |
| Model Number | NCM-SMEQ |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVENUE SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-31 |