MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-01-15 for PACKAGE ASSEMBLY,INFANT FLOW,LP 7772020LP manufactured by Vyaire Medical.
[188823347]
At this time, the suspect device has not been returned for evaluation. Investigation is still ongoing. Therefore, no root cause could be determine yet. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[188823348]
The customer reported that the infant flow with a set of continuous positive nasal pressure generator had pressure anomaly (positive expiratory pressure and inspiratory pressure) while in use on a patient that resulted in decreased oxygen saturation (sao2) in the neonate. At first, the operator changed the device with same lot number (lot: 0004076953), but no success. Then they changed the device again with a different lot number (lot: 0004045851) and no recurrence of the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00068 |
| MDR Report Key | 9593438 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-01-15 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-07-11 |
| Date Mfgr Received | 2019-12-17 |
| Date Added to Maude | 2020-01-15 |
| 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 | 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 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION85 PARQUE UNDUSTRIAL MEXICALI III |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PACKAGE ASSEMBLY,INFANT FLOW,LP |
| Generic Name | GENERATOR AND CIRCUITS |
| Product Code | BZD |
| Date Received | 2020-01-15 |
| Model Number | PACKAGE ASSEMBLY,INFANT FLOW,LP |
| Catalog Number | 7772020LP |
| Lot Number | 0004076953 |
| 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 | 1. Required No Informationntervention | 2020-01-15 |