FDA Adverse Event
Injury
Summary report: N
FLOWMETER, CM
MDR report key: 21901013
·
Received April 24, 2025
Report
- Report Number
- 2020813-2025-00002
- Event Type
- Injury
- Date Received
- April 24, 2025
- Date of Event
- April 3, 2025
- Report Date
- April 24, 2025
- Manufacturer
- ACCUTRON INC.
- Product Code
- BSZ
- UDI-DI
- 00813830021141
- PMA / PMN Number
- K970163
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
TESTING WAS CONDUCTED ON THE SUSPECTED DEVICE. AT NO TIME WAS N2O GAS PRESENT WITHOUT THE PRESENCE OF O2 GAS. NITROUS WAS ACCURATE FOR WHOLE RANGE OF 0-70%. DEVICE MEETS FACTORY SPECIFICATIONS.
Description of Event or Problem · 0
THE USER FACILITY REPORTED THAT 3 PATIENTS GOT SICK - INSTANTLY, DURING AND END OF PROCEDURES. ONE PATIENT FAINTED. NO EMERGENCY SERVICES WERE CALLED AND NO PATIENTS VOMITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1275997 | FLOWMETER, CM | FLOWMETER | BSZ | 31970 | 00813830021141 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |