MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-30 for CHEMETRON ADAPTER DISS MALE OXY USA AD-CHUO-DM manufactured by Chemetron Amvex Corporation.
[27674178]
The connector separate from main body slowly with use. When you connect to the wall oxygen, it does not catch. This prevents the pt from getting full oxygen. This problem occurred overtime. It is a problem with the device as it wears but there wasn't a significant event that affected a pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5056840 |
| MDR Report Key | 5129973 |
| Date Received | 2015-09-30 |
| Date of Report | 2015-09-30 |
| Date of Event | 2015-09-22 |
| Date Added to Maude | 2015-10-06 |
| 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 |
| 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 | 0 |
| Brand Name | CHEMETRON ADAPTER DISS MALE OXY USA |
| Generic Name | CHEMETRON ADAPTER DISS MALE OXY USA |
| Product Code | CBO |
| Date Received | 2015-09-30 |
| Catalog Number | AD-CHUO-DM |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHEMETRON AMVEX CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-30 |