FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 714516
·
Received May 11, 2006
Report
- Report Number
- 8020893-2006-00145
- Event Type
- Malfunction
- Date Received
- May 11, 2006
- Date of Event
- May 1, 2006
- Report Date
- May 11, 2006
- Manufacturer
- PURITAN-BENNETT CORP
- Product Code
- CBK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 PATIENT. THE PATIENT 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 BREATH DELIVERY UNIT PCG. 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 | UNKNOWN |