FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 1060166
·
Received June 11, 2008
Report
- Report Number
- 8020893-2008-00264
- Event Type
- Malfunction
- Date Received
- June 11, 2008
- Date of Event
- May 13, 2008
- Report Date
- May 14, 2008
- Manufacturer
- PURITAN-BENNETT CORP
- Product Code
- CBK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
AS PER CUSTOMER, THE VENTILATOR STOPPED CYCLING DUE TO PROCEDURE ERROR.
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. THE PURITAN BENNET CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE. NO PROBLEM FOUND. 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |