FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2023054
·
Received February 24, 2011
Report
- Report Number
- 1720753-2011-01607
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REP FOUND THE SURGE SUPPRESSOR PCB WAS FAULTY. PCB WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE 2800 SYSTEM WORKSTATION FAILED TO BOOT UP. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |