FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 1062037
·
Received June 13, 2008
Report
- Report Number
- 8020893-2008-00279
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 4, 2008
- Manufacturer
- PURITAN-BENNETT CORP.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PURITAN BENNETT WAS NOT AUTHORIZED TO REPAIR THE UNIT. THE CUSTOMER REPORTED TO HAVE REPLACED THE BDU CPU. THE PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) CONDUCTED FINAL TESTING.
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 |