FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3231822
·
Received July 15, 2013
Report
- Report Number
- 8020893-2013-01596
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 9, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AN 840 VENTILATOR HAD AN ERRATIC DISPLAY. NO PATIENT INVOLVEMENT. COVIDIEN TECH SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH CUSTOMER OVER THE PHONE. THE CUSTOMER WILL SWAP THE BACKLIGHT INVERTER PCBS TO TRY AND ISOLATE THE PROBLEM. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327775 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |