MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-12-20 for P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER 10011A manufactured by Vyaire Medical.
[131045620]
(b)(4). Any additional information received from the customer will be included in a follow-up report. At this time, the suspect device has not been received for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[131045621]
The customer reported while using the low flow microblender; the loss of oxygen/air high pressure alarm fails. The customer performed troubleshooting, but the issue went unresolved. The customer reported there is no patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2018-09691 |
| MDR Report Key | 8185186 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-12-20 |
| Date of Report | 2018-11-21 |
| Date of Event | 2018-11-21 |
| Date Mfgr Received | 2018-11-21 |
| Device Manufacturer Date | 2013-07-01 |
| Date Added to Maude | 2018-12-20 |
| 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 | 3 |
| Brand Name | P/N 9320 LOW FLOW AIR/OXYGEN MICROBLENDER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2018-12-20 |
| Model Number | BLENDER |
| Catalog Number | 10011A |
| 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 | 22745 SAVI RANCH PKWY YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |