MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for CAREFUSION AIRLIFE MISTY MAX 10 NEBULIZER 002445 manufactured by Carefusion / Vyaire Medical.
[91457427]
The product (care fusion airlife misty max 10 nebulizer lot # 0001073618) failed to nebulize medication. Secondary nebulizer mask used without issue. Date of use: (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073171 |
| MDR Report Key | 7009578 |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-11-01 |
| Date Added to Maude | 2017-11-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CAREFUSION AIRLIFE MISTY MAX 10 NEBULIZER |
| Generic Name | NEBULIZER |
| Product Code | CCQ |
| Date Received | 2017-11-08 |
| Catalog Number | 002445 |
| Lot Number | 0001073618 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION / VYAIRE MEDICAL |
| Manufacturer Address | YORBA LINDA CA 92887 US 92887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-08 |