MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-27 for INFANT FLOW SIPAP 27476-001 manufactured by Vyaire Medical.
[187718817]
(b)(4). At this time, vyaire has not received the suspect device/component for evaluation. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[187718818]
It was reported to vyaire that the sipap ventilator could not build peep. The customer advised there was no patient involvement associated with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11325 |
| MDR Report Key | 9634700 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-27 |
| Date of Report | 2019-12-08 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2019-12-08 |
| Device Manufacturer Date | 2015-09-04 |
| Date Added to Maude | 2020-01-27 |
| 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 N. 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 | INFANT FLOW SIPAP |
| Generic Name | VENTILATOR, NON-CONTINUOUS |
| Product Code | BZD |
| Date Received | 2020-01-27 |
| Model Number | INFANT FLOW SIPA |
| Catalog Number | 27476-001 |
| 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 | 2020-01-27 |