FDA Adverse Event
Malfunction
Summary report: N
HT70 VENTILATOR
MDR report key: 3193116
·
Received June 25, 2013
Report
- Report Number
- 2023050-2013-00444
- Event Type
- Malfunction
- Date Received
- June 25, 2013
- Date of Event
- June 5, 2013
- Report Date
- June 7, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REPORTEDLY, DURING PT USE, THE PARAMETERS (ALARM AND SETTINGS) COULD NOT BE ADJUSTED. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE PT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288730 | HT70 VENTILATOR | CBK, NOU | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |