FDA Adverse Event
Malfunction
Summary report: N
C-ARM
MDR report key: 1812075
·
Received August 17, 2010
Report
- Report Number
- 9617766-2010-00473
- Event Type
- Malfunction
- Date Received
- August 17, 2010
- Date of Event
- July 26, 2010
- Report Date
- August 17, 2010
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CUSTOMER WAS INSTRUCTED REGARDING THE AUTOMATIC MODE FOR KV AND MA. ALSO, THE POWER PLUG WAS REPAIRED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED INTERMITTENTLY THE SYSTEM DISPLAYED BLACK IMAGES. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | C-ARM | FLUOROSCOPY X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |