MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-28 for INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION INFANT FLOW SIPAP 27476-001 manufactured by Vyaire Medical.
[187719171]
(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 returned for evaluation. Therefore, no root cause could be determine yet.
Patient Sequence No: 1, Text Type: N, H10
[187719172]
The customer reported to vyaire that the sipap device would not build up any pressure. At this time, there is no information regarding patient involvement associated with the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11293 |
| MDR Report Key | 9639957 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-28 |
| Date of Report | 2019-12-30 |
| Date of Event | 2019-12-30 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2016-02-26 |
| Date Added to Maude | 2020-01-28 |
| 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 | MS. MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA CA 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 PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION |
| Generic Name | VENTILATOR, NON-CONTINUOUS |
| Product Code | BZD |
| Date Received | 2020-01-28 |
| Model Number | INFANT FLOW SIPAP |
| 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 | 2020-01-28 |