MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-29 for AERONEB PROFESSIONAL SYSTEM manufactured by Aerogen Ltd..
[176851030]
Arrived in patient room for treatment, discovered approximately 2ml of fluid in aerogen medication cup (aerogen # lpch 64202). Fluid withdrawn from medication cup. Tested aerogen with normal saline, aerogen's lights shut off and stopped misting within 10 seconds of being turned on. All cables, wires, looked fine. Aerogen red flagged and removed from service. New aerogen installed in patient's room, medication treatment delivered without further event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9643443 |
| MDR Report Key | 9643443 |
| Date Received | 2020-01-29 |
| Date of Report | 2020-01-10 |
| Date of Event | 2019-12-28 |
| Report Date | 2020-01-10 |
| Date Reported to FDA | 2020-01-10 |
| Date Reported to Mfgr | 2020-01-29 |
| Date Added to Maude | 2020-01-29 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AERONEB PROFESSIONAL SYSTEM |
| Generic Name | NEBULIZER (DIRECT PATIENT INTERFACE) |
| Product Code | CAF |
| Date Received | 2020-01-29 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AEROGEN LTD. |
| Manufacturer Address | GALWAY BUSINESS PARK DANGAN GALWAY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-29 |