FDA Adverse Event
Injury
Summary report: N
INNOVA 3100-IQ
MDR report key: 3640731
·
Received January 31, 2014
Report
- Report Number
- 9611343-2014-00046
- Event Type
- Injury
- Date Received
- January 31, 2014
- Date of Event
- October 30, 2013
- Report Date
- January 2, 2014
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- OWB
- PMA / PMN Number
- K052412
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS HIGH AIR-KERMA DOSE, NOT POSSIBLY REDUCED TO THE LOWEST BY USING DOSE REDUCTION FEATURES PROVIDED BY THE SYSTEM, IS LIKELY TO RESULT IN A SERIOUS INJURY SINCE IT MAY TAKE SOME TIMES BEFORE HAVING ANY RADIATION BURN. 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
DURING AN INTERNAL VOLUNTARY ANALYSIS PERFORMED BY A GE HEALTHCARE EMPLOYEE OF A REMOTELY CONNECTED SYSTEM, HE IDENTIFIED ON (B)(6) 2014, MULTIPLE PTS WHO RECEIVED HIGH DOES ON ONE SPECIFIC INNOVA 3100-IQ (B)(6). THIS REPORT IS ASSOCIATED TO PT #40 WHO RECEIVED 7.2 GY ON (B)(6) 2013. THERE WAS NO SYSTEM FAILURE OR MALFUNCTION AND NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 68261 | INNOVA 3100-IQ | INTERVENTIONAL FLUOROSCOPIC X-RAY | OWB | GE MEDICAL SYSTEMS SCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |