FDA Adverse Event
Malfunction
Summary report: N
E360 VENTILATOR
MDR report key: 3082602
·
Received April 23, 2013
Report
- Report Number
- 2023050-2013-00329
- Event Type
- Malfunction
- Date Received
- April 23, 2013
- Date of Event
- March 28, 2013
- Report Date
- April 4, 2013
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- 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
THOUGH REQUESTED, PT INFORMATION WAS NOT PROVIDED.
Description of Event or Problem · 1
REPORTEDLY, DURING PT USE, A 'LOW FIO2' ALARM OCCURRED WHICH COULD NOT BE SOLVED BY CALIBRATING THE OXYGEN SENSOR. THE SENSOR WAS REPLACED AND THIS ISSUE WAS RESOLVED. THERE WAS NO MEDICAL INTERVENTION OR ADVERSE PT EFFECTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 173491 | E360 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |