FDA Adverse Event
Malfunction
Summary report: N
HT70 VENTILATOR
MDR report key: 3102603
·
Received May 1, 2013
Report
- Report Number
- 2023050-2013-00368
- Event Type
- Malfunction
- Date Received
- May 1, 2013
- Date of Event
- March 5, 2013
- Report Date
- April 15, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTEDLY, DURING TESTING, AFTER STARTING THE UNIT, THE TOUCH PANEL DID NOT WORK. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 190379 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |