MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for PENLON SIGMA DELTA manufactured by Dre, Inc Dba Avante Health Solutions.
[184481939]
Patient in operation room for coronary artery bypass graft (cabg) surgery. While on bypass, perfusion noticed that her isoflurane was leaking from her machine. Nurse manager made aware. The operation room team made aware. Some members of the team felt effects of gas (ex. Dizzy, lightheaded) and had to leave room for periods of time, manager aware. Gas was turned off by perfusion, as soon as was possible. Procedure finished without incident to the patient. Manufacturer response for anethesia unit vapo, dre sigma delta (per site reporter). They recommended sending unit back. It was calibrated in (b)(6) 2019 so the assessment/repair may fall under warranty.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9865004 |
| MDR Report Key | 9865004 |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-21 |
| Report Date | 2020-03-04 |
| Date Reported to FDA | 2020-03-04 |
| Date Reported to Mfgr | 2020-03-23 |
| Date Added to Maude | 2020-03-23 |
| 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 | PENLON SIGMA DELTA |
| Generic Name | VAPORIZER, ANESTHESIA, NON-HEATED |
| Product Code | CAD |
| Date Received | 2020-03-23 |
| Model Number | SIGMA DELTA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DRE, INC DBA AVANTE HEALTH SOLUTIONS |
| Manufacturer Address | 2601 STANLEY GAULT PKWY SUITE 101 LOUISVILLE KY 40223 US 40223 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |