FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2030253
·
Received March 7, 2011
Report
- Report Number
- 9617766-2011-00541
- Event Type
- Malfunction
- Date Received
- March 7, 2011
- Date of Event
- January 3, 2011
- Report Date
- March 7, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED NOR DUPLICATED. REGARDLESS, PREEMPTIVE REPAIRS WERE PERFORMED. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM FAILED TO DISPLAY AN IMAGE. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC XRAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |