MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-01-10 for INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION 27444-001 manufactured by Vyaire Medical.
[181174820]
(b)(4). At this time, vyaire medical has not receive the device for evaluation. Once received and evaluated, a follow-up medwatch report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[181174821]
It was reported to vyaire medical that the unit had no pressure while in cpap mode. There was no report of any patient involvement associated with this reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11250 |
| MDR Report Key | 9576169 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-01-10 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-05 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2016-02-29 |
| Date Added to Maude | 2020-01-10 |
| 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 | MR. 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 | INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION |
| Generic Name | VENTILATOR, NON-CONTINUOUS |
| Product Code | BZD |
| Date Received | 2020-01-10 |
| Model Number | SIPAP |
| Catalog Number | 27444-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-10 |