MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-06-18 for BIRD HIGH FLOW BLENDER SERIES 03800A manufactured by Vyaire Medical, Inc.
[111441832]
(b)(4). Any additional information received from the customer will be included in a follow-up report. Results of investigation: the suspect device was returned to vyaire's factory service for evaluation and repair. An investigation was performed and the reported event was unable to be confirmed or duplicated. The device was tested and reading to specifications.
Patient Sequence No: 1, Text Type: N, H10
[111441833]
The customer reported while using the bird high flow blender series; the fraction of inspired oxygen (fio2) is out of specifications. The customer reported setting an external analyzer and the readings is off. The customer reported there is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-07995 |
| MDR Report Key | 7611897 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-18 |
| Date of Report | 2018-06-18 |
| Date of Event | 2018-06-06 |
| Date Mfgr Received | 2018-06-06 |
| Device Manufacturer Date | 1995-01-01 |
| Date Added to Maude | 2018-06-18 |
| 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 | AVERY FOSTER |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | 1100 BIRD CENTER DR. |
| 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 | 3 |
| Brand Name | BIRD HIGH FLOW BLENDER SERIES |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2018-06-18 |
| Returned To Mfg | 2018-06-13 |
| Model Number | BLENDER |
| Catalog Number | 03800A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | 22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-18 |