FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 1441157
·
Received August 18, 2009
Report
- Report Number
- 1720753-2009-02962
- Event Type
- Malfunction
- Date Received
- August 18, 2009
- Date of Event
- March 18, 2009
- Report Date
- April 8, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE GE SERVICE REP REPLACED THE BATTERIES. THE SYSTEM FUNCTIONS AS INTENDED. (B) (4) 06/17/2009.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN ERROR MESSAGE DURING BOOT UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |