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 2018-07-13 for BIRD SENTRY AIR/OXYGEN MICROBLENDER 03800A manufactured by Vyaire Medical.
[114009519]
(b)(4). At this time, vyaire has not received the suspect device/component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[114009520]
The customer reported while using the avea ventilator, it is reading higher fio2 then the set, and is out of specification. The customer stated there was no patient involvement associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-09060 |
| MDR Report Key | 7687070 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-13 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-06-21 |
| Date Mfgr Received | 2018-06-21 |
| Date Added to Maude | 2018-07-13 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer Phone | 8727570116 |
| Manufacturer G1 | VYAIRE MEDICAL INC. |
| 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 SENTRY AIR/OXYGEN MICROBLENDER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2018-07-13 |
| Model Number | MICROBLENDER |
| Catalog Number | 03800A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL |
| Manufacturer Address | 26125 NORTH RIVERWOODS BLVD METTAWA IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-13 |