FDA Adverse Event
Malfunction
Summary report: N
WOB
MDR report key: 16281024
·
Received February 1, 2023
Report
- Report Number
- 3003764448-2023-00001
- Event Type
- Malfunction
- Date Received
- February 1, 2023
- Date of Event
- December 23, 2022
- Manufacturer
- CONTROL DEVICES, LLC
- Product Code
- CAN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
CUSTOMER ALLEGES THAT CONTAINER FAILED TO DISPENSE OXYGEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 99447 | WOB | GAS CYLINDER REGULATOR | CAN | CONTROL DEVICES, LLC | 290799-6 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |