FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 1003334
·
Received February 27, 2008
Report
- Report Number
- 8020893-2008-00083
- Event Type
- Malfunction
- Date Received
- February 27, 2008
- Date of Event
- February 13, 2008
- Report Date
- February 13, 2008
- Manufacturer
- PURITAN-BENNETT CORP
- Product Code
- CBK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
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. THE NELLCOR PURITAN BENNETT CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE INSPIRATORY FLOW SENSOR. THE UNIT PASSED EXTENDED SELF TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 840 VENTILATOR | VENTILATOR | CBK | PURITAN-BENNETT CORP | 840 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |