FDA Adverse Event
Malfunction
Summary report: N
E360 VENTILATOR
MDR report key: 2860067
·
Received November 21, 2012
Report
- Report Number
- 2023050-2012-00297
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- October 25, 2012
- Report Date
- October 30, 2012
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K053502
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH REQUESTED, NO PATIENT INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
DURING PATIENT USE, THE VENTILATOR CONSTANTLY GENERATED A HIGH FI02 ALARM BEFORE AND AFTER PERFORMING THE 02 SENSOR CALIBRATION. THERE WAS NO SERIOUS INJURY REPORTED IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E360 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |