FDA Adverse Event
Injury
Summary report: N
INNOVA 4100-IQ
MDR report key: 2329317
·
Received November 2, 2011
Report
- Report Number
- 9611343-2011-00070
- Event Type
- Injury
- Date Received
- November 2, 2011
- Date of Event
- October 7, 2011
- Report Date
- November 2, 2011
- Manufacturer
- GE MEDICAL SYSTEMS
- Product Code
- MQB
- PMA / PMN Number
- K052412
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
BLOCK A: SERVICE TECHNICIAN INFO WAS NOT PROVIDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE SERVICING AN INNOVA 4100-IQ A SERVICE TECHNICIAN FROM THE HOSPITAL RECEIVED FLASHED BURNS ON BOTH HANDS. THE INCIDENT HAPPENED WHEN THE SERVICE TECHNICIAN WAS TRYING TO TROUBLESHOOT THE HIGH VOLTAGE GENERATOR. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVA 4100-IQ | ANGIOGRAPHIC X-RAY SYSTEM | MQB | GE MEDICAL SYSTEMS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |