FDA Adverse Event
Malfunction
Summary report: N
GENERATOR WITH VERSION 4.0.0 AND 4.1.0
MDR report key: 2479283
·
Received February 29, 2012
Report
- Report Number
- 2953189-2012-00053
- Event Type
- Malfunction
- Date Received
- February 29, 2012
- Date of Event
- February 7, 2012
- Report Date
- February 15, 2012
- Manufacturer
- COVIDIEN
- Product Code
- GXD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012, THAT A CUSTOMER HAD AN ISSUE WITH GENERATOR WITH VERSION 4.0.0 AND 4.1.0. THE CUSTOMER STATES THAT THE POWER CORD OF THE RFG WAS BEGINNING TO BECOME FRAYED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENERATOR WITH VERSION 4.0.0 AND 4.1.0 | GENERATOR WITH VERSION 4.0.0 AND 4.1.0 | GXD | COVIDIEN | RFG2 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |