FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3162054
·
Received June 6, 2013
Report
- Report Number
- 1720753-2013-06802
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Date of Event
- May 23, 2013
- Report Date
- June 6, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY CHARGER BOARD WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THERE WAS SMOKE COMING FROM THE SYSTEM, AND THE SYSTEM FAILED DURING AN EXAM. A BACKUP SYSTEM WAS REQUIRED TO COMPLETE THE CASE. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251536 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |