FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3201737
·
Received June 28, 2013
Report
- Report Number
- 8020893-2013-01429
- Event Type
- Injury
- Date Received
- June 28, 2013
- Date of Event
- May 27, 2013
- Report Date
- May 29, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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 COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND COULD NOT DUPLICATE THE REPORTED FAILURE. NO PARTS WER REPLACED. THE UNIT PASSED EXTENDED SELF TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295851 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |