MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for I-NEB - NEBULIZER manufactured by Respiratory Drug Delivery (uk) Ltd..
[180307262]
Spontaneous call, spouse states that device stopped working yesterday. Spouse is at work and does not have serial number on hand. Spouse reports no changes in breathing. No other info known. Is the actual device available for investigation? Yes. Did we replace device? Yes. Did the pt have a backup device they were able to switch to? Yes. Reported (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093068 |
| MDR Report Key | 9728765 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-06 |
| Date Added to Maude | 2020-02-19 |
| 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 | I-NEB - NEBULIZER |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2020-02-18 |
| Lot Number | UNK |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRATORY DRUG DELIVERY (UK) LTD. |
| Brand Name | 20MCG/ML |
| Product Code | --- |
| Date Received | 2020-02-18 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |