MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-30 for INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION INFANT FLOW SIPAP SIPAP ENGL manufactured by Vyaire Medical.
[185728639]
(b)(4). At this time, the suspect device has not been returned for evaluation. Therefore, no root cause could be determined yet. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[185728640]
The customer reported that the infant flow sipap unit was showing e33 and e30 errors on the display during setup. There was no patient involvement with this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11609 |
| MDR Report Key | 9901079 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Device Manufacturer Date | 2007-08-07 |
| Date Added to Maude | 2020-03-30 |
| 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 |
| 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, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| Manufacturer G1 | VYAIRE MEDICAL |
| Manufacturer Street | 1100 BIRD CENTER DRIVE |
| Manufacturer City | PALM SPRINGS, CA |
| Manufacturer Country | US |
| 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, CONTINUOUS, FACILITY USE |
| Product Code | CBK |
| Date Received | 2020-03-30 |
| Model Number | INFANT FLOW SIPAP |
| Catalog Number | SIPAP ENGL |
| 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 N. RIVERWOODS BLVD. METTAWA, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |