FDA Adverse Event
Malfunction
Summary report: N
HT70 VENTILATOR
MDR report key: 3020967
·
Received March 19, 2013
Report
- Report Number
- 2023050-2013-00201
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Date of Event
- February 22, 2013
- Report Date
- February 22, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS
- Product Code
- CBK
- PMA / PMN Number
- K111146
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
REPORTEDLY, DURING TESTING, THE SCREEN BECAME NON-RESPONSIVE. THERE WAS NO PT INVOLVEMENT IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 114940 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |