MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-31 for INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION INFANT FLOW SIPAP manufactured by Vyaire Medical.
[187731298]
(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 determined yet.
Patient Sequence No: 1, Text Type: N, H10
[187731299]
The customer reported that their sipap ventilator showed e33 and e30 during set up. There is no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2020-11715 |
| MDR Report Key | 9908453 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-31 |
| 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 | 2020-03-31 |
| 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 |
| 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 | 2020-03-31 |
| Model Number | INFANT FLOW SIPAP |
| Catalog Number | SIPAP |
| 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 | 2020-03-31 |