FDA Adverse Event
Malfunction
Summary report: N
LINDE NOXBOXI
MDR report key: 16887665
·
Received May 5, 2023
Report
- Report Number
- MW5117338
- Event Type
- Malfunction
- Date Received
- May 5, 2023
- Date of Event
- March 14, 2023
- Report Date
- May 2, 2023
- Manufacturer
- LINDE GAS & EQUIPMENT, INC.
- Product Code
- MRN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A THICK, WHITE SUBSTANCE THAT IS COMING FROM OUR TANK CONNECTION AND PURGE LINES ON THE BACK OF OUR NITRIC OXIDE DELIVERY SYSTEM NOXBOXI.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 687301 | LINDE NOXBOXI | APPARATUS, NITRIC OXIDE DELIVERY | MRN | LINDE GAS & EQUIPMENT, INC. | NOXBOX-1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |