FDA Adverse Event
Malfunction
Summary report: N
E360 VENTILATOR
MDR report key: 5517897
·
Received March 22, 2016
Report
- Report Number
- 2023050-2016-00173
- Event Type
- Malfunction
- Date Received
- March 22, 2016
- Date of Event
- February 29, 2016
- Report Date
- February 29, 2016
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- PMA / PMN Number
- K053502
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN AUTHORIZED THIRD PARTY SERVICE ENGINEER EVALUATED THE DEVICE, THE SINGLE BOARD COMPUTER PRINTED CIRCUIT BOARD WAS CONFIRMED FAULTY AND NEEDS TO BE REPLACED. SE IS AWAITING SBC PCB TO ARRIVE TO COMPLETE THE REPAIR.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SET UP A VENTILATOR WAS NOT BOOTING UP AND HAD A BLANK DISPLAY. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172497 | E360 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | E360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |