FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2072417
·
Received April 8, 2011
Report
- Report Number
- 1720753-2011-03441
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- February 16, 2011
- Report Date
- April 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE RE-SEATED THE RIBBON CABLE TO THE CONTROL PANEL AND RE-FORMATTED BOTH THE CINE AND THE SOFTWARE HARD DISK DRIVE. THE GENERATOR INTERFACE BOARD AND THE SNUBBER BOARD WERE ALSO REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A COMMUNICATION FAILURE ERROR MESSAGE ON THE 9900 SYSTEM. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |