MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-01-29 for SUNSET OXYGEN SUPPLY TUBING RES3050 AND RES3007 manufactured by .
[134445301]
Maude adverse event report number mw5078464 alleges a consumer experienced a lower oxygen saturation when using sunset brand oxygen tubing and nasal cannula. The report also alleges the consumer experienced increased frequency of falls, dizziness, and elevated resting heart rate. The report alleges after using another brand of oxygen tubing, oxygen saturation increased when on the prescribed oxygen flow rate. A comparative analysis with other marketed oxygen tubing and an evaluation of current devices in stock will be performed. If the results of the evaluation demonstrate a malfunction, an additional narrative will be provided.
Patient Sequence No: 1, Text Type: N, H10
[134445302]
Maude adverse event report number mw5078464.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006446479-2019-00004 |
| MDR Report Key | 8287170 |
| Report Source | CONSUMER |
| Date Received | 2019-01-29 |
| Date Added to Maude | 2019-01-29 |
| 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 Contact | NAZREE WILLIAMS |
| Manufacturer Street | 180 N. MICHIGAN AVE SUITE 2000 |
| Manufacturer City | CHICAGO IL 60601 |
| Manufacturer Country | US |
| Manufacturer Postal | 60601 |
| Manufacturer Phone | 3125332457 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUNSET OXYGEN SUPPLY TUBING |
| Generic Name | OXYGEN SUPPLY TUBING |
| Product Code | BYX |
| Date Received | 2019-01-29 |
| Model Number | RES3050 AND RES3007 |
| Catalog Number | RES3050 AND RES3007 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |