MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-31 for BIRD HIGH FLOW BLENDER MICROBLENDER 3800 manufactured by Vyaire Medical, Inc..
[98664085]
Patient Sequence No: 1, Text Type: N, H10
[98664086]
Reportedly, blender was set to dispense o2 at (b)(6)%. Oxygen analyzed with calibrated analyzer. Oxygen dispensed shown to be (b)(6)%. Blender removed from service and replaced with another blender. Reportedly, the blender was sent for service and was placed back into service a few weeks later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7230356 |
| MDR Report Key | 7230356 |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-11-08 |
| Report Date | 2018-01-19 |
| Date Reported to FDA | 2018-01-19 |
| Date Reported to Mfgr | 2018-01-19 |
| Date Added to Maude | 2018-01-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | BIRD HIGH FLOW BLENDER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2018-01-31 |
| Model Number | MICROBLENDER |
| Catalog Number | 3800 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-31 |