MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-10 for AIRLIFE NEB KIT W ADAPTER STERILE WATER 1000 ML CK0010 manufactured by Vyaire Medical.
[188822761]
The sample device is not available for analysis. Additionally, no photo was available. No investigation can be performed and the defect could not be confirmed. Therefore, root cause of failure could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[188822762]
The customer reported that during use on patient their nebulizer kit's mists works fine initially but when they turn off the flow and restarted it again it does not work anymore. No patient harm was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00067 |
| MDR Report Key | 9578747 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-10 |
| 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 | 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 PRODUCCILON 85 INDUSTRIAL MEXICALI |
| 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 | AIRLIFE |
| Generic Name | HUMIDIFIER NEBULIZER KIT |
| Product Code | CCK |
| Date Received | 2020-01-10 |
| Model Number | NEB KIT W ADAPTER STERILE WATER 1000 ML |
| Catalog Number | CK0010 |
| Lot Number | 4110253 |
| 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. Other | 2020-01-10 |