FDA Adverse Event
Injury
Summary report: N
ULTRA PC% FLOWMETER
MDR report key: 21332938
·
Received February 7, 2025
Report
- Report Number
- 2020813-2025-00001
- Event Type
- Injury
- Date Received
- February 7, 2025
- Date of Event
- January 8, 2025
- Report Date
- February 7, 2025
- Manufacturer
- ACCUTRON INC.
- Product Code
- BSZ
- UDI-DI
- 00813830021158
- PMA / PMN Number
- K970163
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
A COMPLETE AND THOROUGH TEST AND EVALUATION WAS CONDUCTED ON THE DEVICE IN AS RECEIVED CONDITION. TESTING FOUND O2 & N2O MIXED GAS FLOWS WERE WITHIN IN FACTORY TOLERANCES. DEVICE TESTED AND MEETS FACTORY REQUIREMENTS.
Description of Event or Problem · 0
USER FACILITY REPORTED THAT 2 PATIENTS GOT SICK AT 40% FLOW AND DR. WAS CONCERNED ABOUT METER FLOWING ACCURATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1248314 | ULTRA PC% FLOWMETER | FLOWMETER | BSZ | ACCUTRON INC. | 31975 | 00813830021158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |