FDA Adverse Event
Injury
Summary report: N
840 VENTILATOR
MDR report key: 4111519
·
Received September 23, 2014
Report
- Report Number
- 8020893-2014-02243
- Event Type
- Injury
- Date Received
- September 23, 2014
- Report Date
- September 11, 2014
- Manufacturer
- COVIIDIEN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER SERVICE ENGINEER (CSE) HAS NOT YET PERFORMED THE REPAIR.(B)(4).
Description of Event or Problem · 1
COVIDIEN RECEIVED INFORMATION STATING THAT DURING PATIENT USE, THE 840 VENTILATOR HAD A BLANK DISPLAY. THE PATIENT WAS MANUALLY VENTILATED AND TRANSFERRED TO ANOTHER UNIT. THERE WERE NO NEGATIVE PATIENT CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 591942 | 840 VENTILATOR | CONTINUOUS VENTILATOR | CBK | COVIIDIEN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |