FDA Adverse Event
Malfunction
Summary report: N
840 VENTILATOR
MDR report key: 3810764
·
Received March 21, 2014
Report
- Report Number
- 8020893-2014-00674
- Event Type
- Malfunction
- Date Received
- March 21, 2014
- Report Date
- February 20, 2014
- Manufacturer
- GALWAY (RC) - RX
- Product Code
- CBK
- PMA / PMN Number
- K970460
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COVIDIEN CUSTOMER SUPPORT ENGINEER (CSE) INSPECTED THE DEVICE AND VERIFIED THE MALFUNCTION. THE CSE REPLACED THE GRAPHICAL USER INTERFACE (GUI) CENTRAL PROCESSING UNIT (CPU) PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) AND BACKLIGHT INVERTER PCB. THE DEVICE PASSED ALL CALIBRATIONS, SHORT SELF-TEST, EXTENDED SELF-TEST (EST) AND PERFORMANCE VERIFICATION TEST ACCORDING TO MANUFACTURER SPECIFICATIONS. (B)(4).
Description of Event or Problem · 1
A REPORT RECEIVED FORM THE USA STATED THAT AN 840 VENTILATOR EXPERIENCED A BLANK GRAPHICAL USER INTERFACE (GUI). NO PATIENT INVOLVEMENT WAS REPORTED. THE DATE OF THE EVENT IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 169677 | 840 VENTILATOR | CBK | GALWAY (RC) - RX | 840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |