MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for TREX manufactured by Natus Medical Incorporated Dba Excel-tech Ltd. (xltek).
[175414520]
Patient felt that the a-eeg equipment may have been frequently but not constantly interfering with his pm-defibrillator device. The a-eeg batteries and electrodes were removed and patient stated the problem "seemed" to stop. There are no complaints when the a-eeg equipment was connected to him in the lab. There is no known harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9601216 |
| MDR Report Key | 9601216 |
| Date Received | 2020-01-17 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-11-06 |
| Report Date | 2019-12-31 |
| Date Reported to FDA | 2019-12-31 |
| Date Reported to Mfgr | 2020-01-17 |
| Date Added to Maude | 2020-01-17 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | TREX |
| Generic Name | FULL-MONTAGE STANDARD ELECTROENCEPHALOGRAPH |
| Product Code | GWQ |
| Date Received | 2020-01-17 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK) |
| Manufacturer Address | 5955 PACIFIC CENTER BLVD SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |