MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-01 for SUNSET manufactured by .
[137661055]
Device not returned. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[137661056]
Please see user facility report number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006446479-2019-00005 |
| MDR Report Key | 8384114 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-01 |
| Date of Event | 2019-02-03 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2019-03-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 180 N. MICHIGAN AVE SUITE 2000 |
| Manufacturer City | CHICAGO IL 60601 |
| Manufacturer Country | US |
| Manufacturer Postal | 60601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNSET |
| Generic Name | OXYGEN SUPPLY TUBING |
| Product Code | BYX |
| Date Received | 2019-03-01 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2019-03-01 |