MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-10 for CAP NEBULIZER 24 PACK CC10 manufactured by Vyaire Medical.
[188823093]
The sample device is not available for analysis. Therefore, no investigation can be performed. The device history record was reviewed by vyaire and there was no issues found.
Patient Sequence No: 1, Text Type: N, H10
[188823094]
The customer reported that the patient's aerosol humidifier of cc10 cap nebulizer 24 pack has stopped producing mist even though the bottle had water in it and the flow was adequate. Patient stopped receiving humidity resulting in mucus plugging. Emergency tracheostomy change was done and the equipment was removed from the patient. Patient harm is not known at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00065 |
| MDR Report Key | 9575549 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-10 |
| Date of Report | 2019-12-17 |
| Date of Event | 2019-12-17 |
| Date Mfgr Received | 2019-12-17 |
| 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 PRODUCCION 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 | CAP NEBULIZER 24 PACK |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2020-01-10 |
| Model Number | CAP NEBULIZER 24 PACK |
| Catalog Number | CC10 |
| Lot Number | 0004070896 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-01-10 |