MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-11-21 for VELE VENTILATOR DIAMOND SERIES VELE COMP D manufactured by Carfusion.
[20782034]
At 930am on (b)(6) while cna in room, vent screen read "patient set up mode" (ventilator not delivering anything). Rt immediately came in room and selected "resume current settings", and vent was running ok. Oxygen stats never fell.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5039300 |
| MDR Report Key | 4284344 |
| Date Received | 2014-11-21 |
| Date of Report | 2014-11-21 |
| Date of Event | 2014-11-16 |
| Date Added to Maude | 2014-12-01 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VELE VENTILATOR DIAMOND SERIES |
| Generic Name | MECHANICAL VENTILATOR |
| Product Code | ONZ |
| Date Received | 2014-11-21 |
| Model Number | VELE COMP D |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARFUSION |
| Manufacturer Address | SAN DIEGO 92130 92130 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-21 |