MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-13 for NEUROCOM EQUITEST NCM-EQ manufactured by Natus Medical Incorporated.
[114540558]
A biomedical engineering technologist (biomed) with (b)(6) has been brought to the user facility to diagnose the issue and make repairs as necessary. Natus technical service has made multiple attempts to follow up with the biomed to ask for additional information and aid in troubleshooting the device. The biomed was most recently in contact with natus technical service on july 10, 2018 and communication is ongoing. The complaint investigation has not yet reached a conclusion regarding the cause of the issue.
Patient Sequence No: 1, Text Type: N, H10
[114540559]
Natus received a report that a neurocom equitest system generated a large, abnormal sway motion while a university student was standing on the force plate for demonstration purposes. The abnormal motion caused a monitor mounted in the surround to fall to the floor. Following the abnormal motion, the system ceased functioning. No death or serious injury occurred, but a professor (the complainant) supervising the student expressed concerns that the abnormal sway motion the system generated could cause a patient to fall. The equitest system was assembled in may 2001. Prior to the event, the equitest system had been used by the user facility for clinical assessment of patients and for teaching purposes. Natus technical service requested further information regarding the student and the incident. The student did not fall, but the professor was standing behind the student as a spotter. The student was not wearing a safety harness. Natus technical service informed the complainant that the device documentation states that to avoid injury, a patient must wear a safety harness when using a dynamic balance system. This statement is found under the warnings and precautions section of the neurocom balance manager systems ifu p/n 005444.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3018859-2018-00132 |
| MDR Report Key | 7686771 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-13 |
| Date of Report | 2018-06-13 |
| Date of Event | 2017-08-02 |
| Date Mfgr Received | 2018-06-13 |
| Device Manufacturer Date | 2001-05-01 |
| Date Added to Maude | 2018-07-13 |
| 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 | EQUITEST |
| Product Code | KHX |
| Date Received | 2018-07-13 |
| Model Number | NCM-EQ |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-07-13 |