FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 1890252
·
Received October 22, 2010
Report
- Report Number
- 1720753-2010-03705
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- September 28, 2010
- Report Date
- October 22, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY WAS ADJUSTED. A NEW SOFTWARE KIT, FLOPPY DRIVE, ELECTRICALLY ERASABLE READ ONLY MEMORY, AND CENTRAL PROCESSOR WERE ALL REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPY X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |