FDA Adverse Event
Other
Summary report: N
E360 VENTILATOR
MDR report key: 1966501
·
Received January 14, 2011
Report
- Report Number
- 2023050-2011-00002
- Event Type
- Other
- Date Received
- January 14, 2011
- Date of Event
- October 27, 2010
- Report Date
- December 15, 2010
- 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
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REPORTEDLY, THE VENTILATOR WAS CHANGED FROM AC POWERED TO BATTERY POWER WHILE IN USE ON A PATIENT; HOWEVER, THE VENTILATOR DID NOT OPERATE ON BATTERY. IT WAS ALSO REPORTED THAT THERE WAS NO ALARM AT THE TIME OF THE INCIDENT. THE PATIENT WAS MANUALLY VENTILATED UNTIL HE/SHE WAS TRANSFERRED TO A SECOND VENTILATOR. PLEASE NOTE THAT THERE WAS NO SERIOUS INJURY IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E360 VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E360 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |