MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2020-03-10 for CIRCUIT 3100A 38IN F&P 850 4/CS 773996 manufactured by Vyaire Medical..
[188824621]
The suspect device is not available for return, as it was discarded. However, the customer sent the photograph of the portion of circuit that required to be taped to ensure it was tight. No root cause has been determined at this time, since investigation is still ongoing. Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803. 56 if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[188824622]
The customer reported that the circuit 3100a is too loose. As an intervention, they tape the up the loose part. At this time, there is no information regarding patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00089 |
| MDR Report Key | 9813167 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2020-03-10 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-20 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| 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 | CIRCUIT 3100A 38IN F&P 850 4/CS |
| Generic Name | VENTILATOR, HIGH FREQUENCY |
| Product Code | LSZ |
| Date Received | 2020-03-10 |
| Model Number | CIRCUIT 3100A 38IN F&P 850 4/CS |
| Catalog Number | 773996 |
| Lot Number | 0004111999 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2020-03-10 |