MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-31 for VIGILANCE II MONITOR VIG2E manufactured by Edwards Lifesciences.
[146947466]
The product is expected to be returned for analysis; however, it has not yet been received. Upon the return of the product, a supplemental report will be sent with the investigation results as well as the device history record review. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.
Patient Sequence No: 1, Text Type: N, H10
[146947467]
As reported, during use of this vigilance monitor with a patient, the svr (systemic vascular resistance) and ci (cardiac index) values stood still all day and evening and were not noticed by any of the staff. At the beginning of the monitoring, the patient was treated with inotropin in the form of milrinone and dobutamine. The values shown were slightly below the desired values. When the issue was noticed, the staff performed calibration and called an emergency contact in order to attempt to resolve the issue. The patient felt well and was circulatory stable so no new treatment strategies were considered. However, there was a risk that the staff, among other things, could have missed that the patient was not stable and that the withdrawal of inotropin occurred prematurely. There was no allegation of patient injury. The product was available for evaluation. Patient demographics requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01911 |
| MDR Report Key | 8656943 |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-09 |
| Date of Event | 2019-04-25 |
| Date Mfgr Received | 2019-07-12 |
| Device Manufacturer Date | 2011-11-15 |
| Date Added to Maude | 2019-05-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. SAMANTHA EVELEIGH |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492503939 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | VIGILANCE II MONITOR |
| Generic Name | COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE-FUNCTION |
| Product Code | DXG |
| Date Received | 2019-05-31 |
| Model Number | VIG2E |
| Device Expiration Date | 2016-11-15 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-31 |