MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-27 for BIRD HIGH FLOW BLENDER SERIES 03800A manufactured by Vyaire Medical.
[137539737]
Vyaire file identification: (b)(4). Any additional information received from the customer will be included in a follow-up report. The suspect device was returned to vyaire's factory service for evaluation and repair. Factory service was able to confirm the reported event and reported the device is out of calibration. After re-calibrating the device, the issue was resolved. Factory service returned the device back to specifications.
Patient Sequence No: 1, Text Type: N, H10
[137539738]
The customer reported while using the high flow microblender; the fraction of inspired oxygen (fio2) is out of specifications at 30%. The customer reported messing with the knob, adjusting the seat, and now it is all out of specifications. The customer reported to not being trained to perform overhaul of the device and wanted to return the device to vyaire's factory service for evaluation/repair. The customer reported there is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2019-09943 |
| MDR Report Key | 8376007 |
| Date Received | 2019-02-27 |
| Date of Report | 2019-01-29 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Device Manufacturer Date | 2018-02-04 |
| Date Added to Maude | 2019-02-27 |
| 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 | STANLEY TAN |
| Manufacturer Street | 22745 SAVI RANCH PKWY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149193324 |
| Manufacturer G1 | VYAIRE MEDICAL INC. |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BIRD HIGH FLOW BLENDER SERIES |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2019-02-27 |
| Returned To Mfg | 2019-02-05 |
| Model Number | BLENDER |
| Catalog Number | 03800A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-27 |