FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 1040424
·
Received May 7, 2008
Report
- Report Number
- 8020893-2008-00212
- Event Type
- Malfunction
- Date Received
- May 7, 2008
- Date of Event
- May 2, 2008
- Report Date
- May 2, 2008
- Manufacturer
- PURITAN-BENNETT CORP
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PURITAN-BENNETT WAS NOT AUTHORIZED TO EVALUATE THE DEVICE. THE CUSTOMER REPLACED THE BDU BOARD.
Description of Event or Problem · 1
THE SERVICE 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.
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 |