FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 3934253
·
Received June 27, 2014
Report
- Report Number
- 8020893-2014-01502
- Event Type
- Injury
- Date Received
- June 27, 2014
- Date of Event
- January 1, 2014
- Report Date
- May 29, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) EVALUATED THE UNIT, AND VERIFIED THE REPORTED MALFUNCTION. THE CSE INSTALLED THE 15K COMPRESSOR PM KIT, WHICH RESOLVED THE CUSTOMER REPORTED ISSUE. THE UNIT PASSED ALL TESTS AND CALIBRATIONS, AND IT WAS OBSERVED TO BE OPERATING WITHIN MANUFACTURING SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY A CUSTOMER IN THE USA THAT, DURING PATIENT USE, AN 840 VENTILATOR COMPRESSOR STOPPED CYCLING. THE PATIENT WAS TAKEN OFF THE VENTILATOR. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 377302 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT IRELAND | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |