FDA Adverse Event
Injury
Summary report: N
E360 VENTILATOR
MDR report key: 6195144
·
Received December 21, 2016
Report
- Report Number
- 2023050-2016-00773
- Event Type
- Injury
- Date Received
- December 21, 2016
- Date of Event
- November 2, 2013
- Report Date
- April 29, 2014
- 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). THE SERVICE ENGINEER (SE) INSPECTED THE DEVICE AND WAS NOT ABLE TO DUPLICATE THE REPORTED CONDITION. THE SE FOUND THAT THE TWO WIRE CONNECTOR ON THE DISPLAY CABLE HAD BECOME DISCONNECTED. THE SE PERFORMED EXTENDED SELF-TESTING ON THE DEVICE AND ALL TESTS PASSED.
Description of Event or Problem · 1
IT WAS REPORTED THAT, WHILE IN USE ON PATIENT THE AUDIBLE ALARM ON AN E360 VENTILATOR WAS NOT GENERATED. THE PATIENT WAS REMOVE FROM THE VENTILATOR AND PLACED ON AN ALTERNATE VENTILATOR. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 845856 | E360 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | E360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |