FDA Adverse Event
Malfunction
Summary report: N
E500 VENTILATOR
MDR report key: 3060899
·
Received April 10, 2013
Report
- Report Number
- 2023050-2013-00307
- Event Type
- Malfunction
- Date Received
- April 10, 2013
- Date of Event
- March 15, 2013
- Report Date
- March 19, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K061094
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH REQUESTED, NO PT INFO WAS PROVIDED.
Description of Event or Problem · 1
DURING PT USE, AN 'O2 SENSOR BAD' ALARM OCCURRED. CALIBRATING THE O2 SENSOR COULD NOT SOLVE THE ISSUE. THIS ISSUE WAS RESOLVED BY REPLACING THE O2 SENSOR. NO PT INJURY WAS REPORTED IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 148243 | E500 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E500 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |