FDA Adverse Event
Malfunction
Summary report: N
E360 VENTILATOR
MDR report key: 3032690
·
Received March 29, 2013
Report
- Report Number
- 2023050-2013-00246
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- February 6, 2013
- Report Date
- March 11, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS
- Product Code
- CBK
- PMA / PMN Number
- K053502
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH REQUESTED, NO PATIENT INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
DURING PATIENT USE, A 'HIGH FIO2' ALARM OCCURRED. CALIBRATING THE O2 SENSOR COULD NOT SOLVE THE ISSUE. THIS ISSUE WAS RESOLVED BY REPLACING THE O2 SENSOR. NO PATIENT INJURY WAS REPORTED IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 129803 | E360 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS | E360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |