FDA Adverse Event
Malfunction
Summary report: N
CHEMETRON ADAPTER DISS MALE OXY USA
MDR report key: 5129973
·
Received September 30, 2015
Report
- Report Number
- MW5056840
- Event Type
- Malfunction
- Date Received
- September 30, 2015
- Date of Event
- September 22, 2015
- Report Date
- September 30, 2015
- Manufacturer
- CHEMETRON AMVEX CORPORATION
- Product Code
- CBO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 644426 | CHEMETRON ADAPTER DISS MALE OXY USA | CHEMETRON ADAPTER DISS MALE OXY USA | CBO | CHEMETRON AMVEX CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |