FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 1133413
·
Received August 22, 2008
Report
- Report Number
- 8020893-2008-00429
- Event Type
- Malfunction
- Date Received
- August 22, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 19, 2008
- Manufacturer
- PURITAN-BENNETT CORP
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
THE SVC REPORT SHOWS THE CUSTOMER REPORTED THAT THE 840 VENTILATOR STOPPED CYCLING WHILE IN USE ON A PT. THE PT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT. THE EVAL OF THE VENT HAS NOT BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 840 VENTILATOR | VENTILATOR | CBK | PURITAN-BENNETT CORP | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |