FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2030234
·
Received March 7, 2011
Report
- Report Number
- 1720753-2011-01991
- Event Type
- Malfunction
- Date Received
- March 7, 2011
- Date of Event
- February 10, 2011
- Report Date
- March 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SVC REP PERFORMED AN ON SITE INVESTIGATION. THE LEMO CONNECTOR AND THE INTERFACE BOARD WERE REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A COMMUNICATION FAILED ERROR MESSAGE ON THE 9900 SYSTEM. NO PT 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 |