MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for VENTAVIS INEB ADD SYST manufactured by Unk.
[185189173]
Received a spontaneous call, per the pt, her ineb device does not beep, treatment times are too long and it is not delivering medication when it is vibrating. A replacement was sent out to the pt for the next morning. Pt did not report any adverse events as a result of the malfunctioning device. Serial # (b)(4). No further details provided. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093923 |
| MDR Report Key | 9877813 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-09 |
| Date Added to Maude | 2020-03-25 |
| 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 HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VENTAVIS INEB ADD SYST |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2020-03-24 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | 20MCG/ML |
| Product Code | --- |
| Date Received | 2020-03-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |