MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-17 for EXPRESSION manufactured by Invivo Corporation.
[175414173]
Just after placing patient under general anesthesia the monitor died (while plugged in) and was unable to be turned on for another several minutes. Electrical smell coming from the monitor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9601479 |
| MDR Report Key | 9601479 |
| Date Received | 2020-01-17 |
| Date of Report | 2019-11-07 |
| Date of Event | 2019-11-04 |
| Report Date | 2019-11-07 |
| Date Reported to FDA | 2019-11-07 |
| 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 | 3 |
| 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 | EXPRESSION |
| Generic Name | MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS) |
| Product Code | MWI |
| Date Received | 2020-01-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVIVO CORPORATION |
| Manufacturer Address | 12151 RESEARCH PKWY ORLANDO FL 32826 US 32826 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-17 |