FDA Adverse Event
Injury
Summary report: N
NEWPORT
MDR report key: 5071963
·
Received September 11, 2015
Report
- Report Number
- 2023050-2015-00190
- Event Type
- Injury
- Date Received
- September 11, 2015
- Date of Event
- August 13, 2015
- Report Date
- August 20, 2015
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- PMA / PMN Number
- K090888
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE IN USE ON A PATIENT, THE VENTILATOR SCREEN FROZE DURING START UP. THE PATIENT WAS REMOVED FROM THE VENTILATOR AND TRANSFERRED TO ANOTHER VENTILATOR WITHOOUT ANY REPORTED PATIENT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 601988 | NEWPORT | CONTINUOUS VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT70 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |