FDA Adverse Event
Malfunction
Summary report: N
HT70 VENTILATOR
MDR report key: 3040316
·
Received April 3, 2013
Report
- Report Number
- 2023050-2013-00260
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- February 26, 2013
- Report Date
- March 14, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTEDLY, DURING TESTING, IT WAS FOUND THAT THE DOWN ARROW BUTTON ON THE FRONT PANEL DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136890 | HT70 VENTILATOR | NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |