FDA Adverse Event
Malfunction
Summary report: N
HT70 PLUS VENTILATOR
MDR report key: 2941297
·
Received January 31, 2013
Report
- Report Number
- 2023050-2013-00076
- Event Type
- Malfunction
- Date Received
- January 31, 2013
- Date of Event
- January 18, 2013
- Report Date
- January 18, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K111146
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTEDLY, DURING TESTING, IT WAS FOUND THAT THE VENTILATOR DID NOT RECOGNIZE THE EXTERNAL BATTERY. THERE WAS NO PT INVOLVEMENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 43159 | HT70 PLUS VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70PM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |