FDA Adverse Event
Death
Summary report: N
NEWPORT HT50 VENTILATOR
MDR report key: 587795
·
Received April 5, 2005
Report
- Report Number
- 2023050-2005-00007
- Event Type
- Death
- Date Received
- April 5, 2005
- Date of Event
- November 11, 2004
- Report Date
- March 31, 2005
- Manufacturer
- NEWPORT MEDICAL INSTRUMENTS, INC.
- Product Code
- CBK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT WAS NO THE VENTILATOR, THEN THE VENTILATOR ALARMED. PT WAS BAGGED. WHILE ON THE WAY TO THE HOSP, PT PASSED AWAY. (NO ADDITIONAL INFO IS AVAILABLE DUE TO THE REASON THAT THE DECEASED PT'S FAMILY WAS UNWILLING TO COOPERATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEWPORT HT50 VENTILATOR | VENTILATOR | CBK | NEWPORT MEDICAL INSTRUMENTS, INC. | HT50-H1 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Death |