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 2018-10-24 for MIXER, BREATHING GASES, ANESTHESIA INHALATION MICROBLENDER 03800A manufactured by Vyaire Medical.
[124964014]
(b)(4). At this time, vyaire has not received the suspect device/component for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[124964015]
The customer reported that while using the micro blender, the fio2 was 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 | 2021710-2018-09465 |
| MDR Report Key | 8002318 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-10-24 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-27 |
| Date Mfgr Received | 2018-09-27 |
| Device Manufacturer Date | 2004-11-12 |
| Date Added to Maude | 2018-10-24 |
| 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 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 | 3 |
| Brand Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Generic Name | BIRD SENTRY AIR/OXYGEN MICROBLENDER |
| Product Code | BZR |
| Date Received | 2018-10-24 |
| 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 | 2018-10-24 |