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 2018-06-14 for BIRD HIGH FLOW BLENDER SERIES 03800A manufactured by Vyaire Medical, Inc.
[111096302]
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. An investigation was performed and was unable to be confirmed as fio2 was in specifications. The o2/air inlet alarm was able to be confirmed as the most likely cause of the issue was due to a faulty alarm cap. The device was repaired and returned to service specifications.
Patient Sequence No: 1, Text Type: N, H10
[111096303]
The customer reported while using the bird high flow blender series; the fraction of inspired oxygen (fio2) is off by twenty percent. The customer reported the o2/air inlet alarms are not working when one of the gases is disconnected. The customer reported there is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-07949 |
| MDR Report Key | 7601989 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-14 |
| Date of Report | 2018-06-14 |
| Date of Event | 2018-05-16 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2013-12-01 |
| Date Added to Maude | 2018-06-14 |
| 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 | 2018-06-14 |
| Returned To Mfg | 2018-06-08 |
| 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 | 2018-06-14 |