FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2062066
·
Received April 6, 2011
Report
- Report Number
- 1720753-2011-03285
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 7, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPLACED THE POWER PLUG, TIGHTENED THE STEERING LINKAGE, AND REPLACED THE CLIMAX COUPLER. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A BROKEN PLUG, LOOSE STEERING, AND A COMMUNICATIONS ERROR MESSAGE ON THE 9800 SYSTEM. NO PATIENT INJURY WAS 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 |