MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-28 for CC MONITOR VIG2 manufactured by Edwards Lifesciences.
[147952479]
The product is anticipated to be returned. Upon completion of the evaluation, a supplemental report will be completed. The device history record was reviewed; there were no related non-conformances that were found.
Patient Sequence No: 1, Text Type: N, H10
[147952480]
It was reported that there were incorrect co/cco values that were displayed during patient monitoring while using a vigilance ii monitor. The other components involved were eliminated as suspect. The cco cable was tested at the facility and it passed. The swan ganz catheter was eliminated as suspect as when the vig2 was exchanged for a different monitor, then everything worked. It is unknown if there were infusions given during use. It is unknown if the bsa information entered was correct. There was no inappropriate patient treatment reported. There was no patient harm or injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2019-01886 |
| MDR Report Key | 8648391 |
| Date Received | 2019-05-28 |
| Date of Report | 2019-05-06 |
| Date of Event | 2019-05-06 |
| Date Mfgr Received | 2019-06-06 |
| Device Manufacturer Date | 2010-03-01 |
| Date Added to Maude | 2019-05-28 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS LYNN THOMAS |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| Manufacturer G1 | EDWARDS LIFESCIENCES |
| 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 | CC MONITOR VIG2 |
| Generic Name | VIGILANCE II MONITOR |
| Product Code | DXG |
| Date Received | 2019-05-28 |
| Model Number | VIG2 |
| Device Expiration Date | 2015-03-01 |
| 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 | 2019-05-28 |