FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3962768
·
Received June 23, 2014
Report
- Report Number
- 8020893-2014-01526
- Event Type
- Malfunction
- Date Received
- June 23, 2014
- Date of Event
- May 23, 2014
- Report Date
- June 2, 2014
- Manufacturer
- COVIDIEN, FORMERLY NELLCO
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) VERIFIED THE MALFUNCTION. THE CSE INSPECTED THE DEVICE AND REPLACED THE BREATH DELIVERY UNIT (BDU) PRINTED CIRCUIT BOARD (PCB). THE CSE UPGRADED THE SOFTWARE TO THE CURRENT REVISION AND PERFORMED THE EXTENDED SELF-TEST (EST), SHORT SELF-TEST (SST) AND THE PERFORMANCE VERIFICATION TEST (PVT); THE DEVICE OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. COVIDIEN REFERENCE: (B)(4).
Description of Event or Problem · 1
A REPORT RECEIVED FROM (B)(6) STATED AN 840 VENTILATOR FAILED THE POWER ON SELF TEST (POST) WHILE BEING USED ON A PT. THE VENTILATOR WAS REPORTED TO BE SET IN BILEVEL MODE. THERE WAS NO REPORT OF PT HARM AS A RESULT OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 364613 | 840 VENTILATOR | CBK | COVIDIEN, FORMERLY NELLCO | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |