FDA Adverse Event
Other
Summary report: N
INNOVA 2100-IQ
MDR report key: 3487774
·
Received November 13, 2013
Report
- Report Number
- 9611343-2013-00033
- Event Type
- Other
- Date Received
- November 13, 2013
- Date of Event
- October 12, 2013
- Report Date
- October 14, 2013
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- OWB
- PMA / PMN Number
- K052412
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
GE HEALTHCARE'S INVESTIGATION IS ONGOING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT REC'D A PEAK SKIN DOSE AROUND 10 GY IN THE SAME BODY AREA DURING AN EXAM WITH AN INNOVA 2100-IQ SYSTEM. THE TOTAL DOSE REC'D BY THE PT WAS AROUND 16 GY. THERE WAS NO SYSTEM FAILURE OR MALFUNCTION AND NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587907 | INNOVA 2100-IQ | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM | OWB | GE MEDICAL SYSTEMS SCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |