FDA Adverse Event
Injury
Summary report: N
E360 VENTILATOR
MDR report key: 6164999
·
Received December 11, 2016
Report
- Report Number
- 2023050-2016-00734
- Event Type
- Injury
- Date Received
- December 11, 2016
- Date of Event
- September 5, 2016
- Report Date
- November 11, 2016
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- PMA / PMN Number
- K053502
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT, WHILE IN USE ON A PATIENT, THE E360 VENTILATOR GENERATED A HIGH FRACTION OF INSPIRED OXYGEN (FIO2) ALARM. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816178 | E360 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | E360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |