FDA Adverse Event
Death
Summary report: N
INSPIRATION LS VENTILATOR SYSTEM
MDR report key: 3565112
·
Received January 6, 2014
Report
- Report Number
- 3006135941-2014-00001
- Event Type
- Death
- Date Received
- January 6, 2014
- Report Date
- January 3, 2014
- Manufacturer
- EVENT MEDICAL LTD.
- Product Code
- CBK
- PMA / PMN Number
- K072590
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOSPITAL IN (B)(6) INDICATES VENTILATOR SHUTDOWN WHILE ON A PT. THE PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 7297 | INSPIRATION LS VENTILATOR SYSTEM | VENTILATOR | CBK | EVENT MEDICAL LTD. | LS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |