FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 1840650
·
Received September 17, 2010
Report
- Report Number
- 8020893-2010-00470
- Event Type
- Malfunction
- Date Received
- September 17, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 25, 2010
- Manufacturer
- PURITAN BENNETT CORP
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
TECHNICAL SUPPORT ENGINEER TROUBLESHOOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE.
Description of Event or Problem · 1
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 CUSTOMER REPORTED TO HAVE REPLACED THE PSOL ASSEMBLY. THE VENT PASSED ALL TESTING.
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 |