FDA Adverse Event
Malfunction
Summary report: N
RF 3000 GENERATOR
MDR report key: 1052730
·
Received May 23, 2008
Report
- Report Number
- 3005099803-2008-00539
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 22, 2008
- Report Date
- April 25, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- GEI
- PMA / PMN Number
- K981672
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HISTORY RECORD FOR THE UNIT WAS REVIEWED; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINANT DATABASE REVEALED NO ADDITIONAL COMPLAINTS FOR THE UNIT. THE MARCH 2008 15-MONTH RF GENERATOR PRODUCT FAMILY COMPLAINT TREND CHART WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.
Description of Event or Problem · 1
IN 2008, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE RF 3000 GENERATOR "WAS NOT REACHING THE CORRECT IMPEDANCE"; IN ADDITION, SERVICE CODE RF38 WAS REPORTED. THE COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RF 3000 GENERATOR | GEI | BOSTON SCIENTIFIC CORPORATION | M00126220R0 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |