MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for I-NEB SYSTEM manufactured by Respironics, Inc..
[183965961]
Spontaneous call, pt stating - i-neb device is displaying error code 22. No averse effect reported. Pt reported sn (b)(4). Pt does not have backup. Did the pt have backup device they were able to switch to? No. "if no, what was the pt instructed to do in able to continue their infusion? Not an infusion. Is the infusion life-sustaining? Not an infusion. " what is the outcome of the event: ongoing. Did the reported product fault occur while in use with the pt? No. Did the product issue cause or contribute to pt or clinical injury? No. Is the actual device available for investigation? Yes. Did we (mfr) replace the device? Yes. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093790 |
| MDR Report Key | 9840588 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-04 |
| Date Added to Maude | 2020-03-17 |
| 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 SYSTEM |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2020-03-16 |
| Lot Number | (01)00383730000 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS, INC. |
| Brand Name | 10MCG/ML |
| Product Code | --- |
| Date Received | 2020-03-16 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |