FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3813529
·
Received March 26, 2014
Report
- Report Number
- 8020893-2014-00699
- Event Type
- Malfunction
- Date Received
- March 26, 2014
- Report Date
- February 24, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCOR PURITAN
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE REPORTED ISSUE. THE CSE REPORTED THE BREATH DELIVERY (BD) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD (PCB) AND INSTALLED REVISION AK SOFTWARE. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST, EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TEST ACCORDING TO MFR SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
A REPORT RECEIVED FROM THE USA STATED AN 840 VENTILATOR BECAME INOPERABLE. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DATE OF THE EVENT IS UNK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 177659 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCOR PURITAN | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |