FDA Adverse Event
Malfunction
Summary report: N
E360 VENTILATOR
MDR report key: 1030548
·
Received April 15, 2008
Report
- Report Number
- 2023050-2008-00025
- Event Type
- Malfunction
- Date Received
- April 15, 2008
- Date of Event
- March 26, 2008
- Report Date
- March 31, 2008
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
AS REPORTED, THE SPEAKER DID NOT EMIT ANY SOUND, THUS NO AUDIBLE ALARM. PLEASE NOTE THERE WAS NO PT INVOLVEMENT IN THIS CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | E360 VENTILATOR | VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | E360 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |