FDA Adverse Event
Death
Summary report: N
E360 VENTILATOR
MDR report key: 5506170
·
Received March 16, 2016
Report
- Report Number
- 2023050-2016-00156
- Event Type
- Death
- Date Received
- March 16, 2016
- Date of Event
- February 18, 2016
- Report Date
- December 20, 2017
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC
- Product Code
- CBK
- PMA / PMN Number
- K053502
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
AN INVESTIGATION WAS PERFORMED AND THE TECHNICIAN FOUND THAT THE REPORTED PROBLEM COULD NOT BE DUPLICATED. NO FAILURE WAS DETECTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING VENTILATOR USE, HOSPITAL STAFF FOUND A PATIENT HAD TURNED PALE AND IMMEDIATELY MANUALLY VENTILATED THE PATIENT. THE REPORTER STATED A VENTILATOR SCREEN WAS DISPLAYED BUT THERE WAS NO VENTILATION SOUND AND NO AUDIBLE ALARM. THE REPORTER STATED THE PATIENT LATER EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 162331 | E360 VENTILATOR | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC | E360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Death |