FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2023066
·
Received February 24, 2011
Report
- Report Number
- 1720753-2011-01612
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 26, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE POWER SUPPLY FOR THE SYSTEM WAS DISCOVERED TO BE AT 4.8VDC. THE POWER SUPPLY WAS ADJUSTED TO 5.2VDC. THE SYSTEM WAS TESTED AND OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTS THE 9800 SYSTEM WILL NOT FLUORO. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |