FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3231799
·
Received July 15, 2013
Report
- Report Number
- 8020893-2013-01597
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- January 1, 2013
- Report Date
- May 2, 2013
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MULTIPLE ATTEMPTS HAVE BEEN MADE TO GET THE REPAIR INFORMATION BUT NO CUSTOMER RESPONSE. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN NEW INFORMATION BECOMES AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 840 VENTILATOR HAD A BLANK DISPLAY. THERE WAS NO PATIENT INVOLVEMENT. COVIDIEN TECHNICAL SUPPORT ENGINEER (TSE) TROUBLESHOT THIS ISSUE WITH THE CUSTOMER OVER THE PHONE. THE CUSTOMER WAS ADVISED TO REPLACE THE GRAPHICAL USER INTERFACE (GUI) CPU PCB. COVIDIEN WAS NOT AUTHORIZED TO SERVICE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 326710 | 840 VENTILATOR | VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |