FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2022228
·
Received February 28, 2011
Report
- Report Number
- 1720753-2011-01721
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. ALL EXTERNAL WORKSTATION POWER CORD WIRES WERE REPAIRED AND TIGHTENED. THE SYSTEM WAS TESTED AND OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9900 SYSTEM DISPLAYS A LINE POWER MALFUNCTION ERROR MESSAGE AND THEN SHUTS DOWN. 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 |