FDA Adverse Event
Injury
Summary report: N
ULTRA DC FLOWMETER
MDR report key: 21039653
·
Received December 30, 2024
Report
- Report Number
- 2020813-2024-00004
- Event Type
- Injury
- Date Received
- December 30, 2024
- Date of Event
- December 6, 2024
- Report Date
- December 30, 2024
- Manufacturer
- ACCUTRON INC.
- Product Code
- BSZ
- UDI-DI
- 00813830021219
- PMA / PMN Number
- K970163
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
DEVICE WAS RECEIVED AND TESTED. MANUFACTURER COULD NOT DUPLICATE REPORTED PROBLEM. EVALUATION OF DEVICE DID FIND THE N20 DISS FITTING #24036 HAD SOME MINOR DAMAGE, BUT DAMAGE WOULD NOT CAUSE A LEAK.
Description of Event or Problem · 0
USER FACILITY REPORTED TO (B)(6) THAT DURING TWO PROCEDURES, PATIENTS WERE ON N20 / O2 LESS THAN 10 MINUTES BEFORE VOMITING. STAFF IN THE ROOM WERE GETTING HEADACHES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1945367 | ULTRA DC FLOWMETER | FLOWMETER | BSZ | ACCUTRON INC. | 31980 | 00813830021219 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |