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 manufactured by Sunset Healthcare Solutions.
[134574199]
Maude adverse event report number mw5077891 alleges a consumer experienced decreased oxygen saturation readings below 90 percent, decreased appetite, ambulation difficulties, anxiety and general weakness when using sunset oxygen tubing. The report alleges the consumer was seen at a care center for dyspnea. The report also alleges the tubing disconnects from the oxygen concentrator. Due to limited information provided and the physical sample not being available, investigation into the sample is not possible. 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
[134574200]
Maude adverse event report number mw5077891.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006446479-2019-00003 |
| MDR Report Key | 8287127 |
| 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 |
| Manufacturer G1 | SUNSET HEALTHCARE SOLUTIONS |
| Manufacturer Street | 180 N. MICHIGAN AVE SUITE 2000 |
| Manufacturer City | CHICAGO IL 60601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 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 | 2019-01-29 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SUNSET HEALTHCARE SOLUTIONS |
| Manufacturer Address | 180 N. MICHIGAN AVE SUITE 2000 CHICAGO IL 60601 US 60601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |