FDA Adverse Event
Malfunction
Summary report: N
FLOWMETER, DIGITAL FLUSHMOUNT
MDR report key: 20966581
·
Received December 18, 2024
Report
- Report Number
- 2020813-2024-00003
- Event Type
- Malfunction
- Date Received
- December 18, 2024
- Date of Event
- October 16, 2024
- Report Date
- December 18, 2024
- Manufacturer
- ACCUTRON INC.
- Product Code
- BSZ
- PMA / PMN Number
- K052335
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- DENTIST
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
MANUFACTURER WAS ABLE TO CONFIRM REPORTED PROBLEM WITH SUSPECTED DEVICE. PROBLEM IS RELATED TO A FAILED MASS FLOW SENSOR ALONG WITH THE MAIN PC BOARD. NOT CLEAR WHY THE SENSOR AND PC BOARD FAILED.
Description of Event or Problem · 0
USER FACILITY REPORTED THAT TWO PATIENTS WENT INTO DEEP SEDATION. BOTH PROCEDURES WERE STOPPED. THERE WAS NO PATIENT HARM, AND NO MEDICAL INTERVENTION WAS NEEDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1987833 | FLOWMETER, DIGITAL FLUSHMOUNT | FLOWMETER | BSZ | ACCUTRON INC. | 27076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |