FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 1133663
·
Received August 20, 2008
Report
- Report Number
- 8020893-2008-00417
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- August 11, 2008
- Report Date
- August 14, 2008
- Manufacturer
- PURITAN-BENNETT CORP.
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER INSTALLED THE BDU PCB. NPB NOT AUTHORIZED TO SERVICE THE VENTILATOR, BUT UPLOADED THE SOFTWARE ONLY. THE VENT PASSED ALL 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 PATIENT. THE PATIENT 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 |