FDA Adverse Event
Malfunction
Summary report: N
GENOSYL DS
MDR report key: 22494900
·
Received July 14, 2025
Report
- Report Number
- MW5172552
- Event Type
- Malfunction
- Date Received
- July 14, 2025
- Date of Event
- June 26, 2025
- Report Date
- July 8, 2025
- Manufacturer
- C2C DEVELOPMENT, LLC
- Product Code
- MRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PRIMARY NITRIC OXIDE DELIVERY DEVICE ALARMED FAILURE AS IT WAS SWITCHING FROM DEPLETED TO THE NEW CARTRIDGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 154373 | GENOSYL DS | APPARATUS, NITRIC OXIDE DELIVERY | MRN | C2C DEVELOPMENT, LLC | GEN 3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 DA | Female | Other |