FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1070810
·
Received July 9, 2008
Report
- Report Number
- 1720753-2008-22843
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- June 12, 2008
- Report Date
- June 24, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS, INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CALL WAS CANCELLED BY THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED CHARGER FAILED ERROR MESSAGE. INTERMITTENT ERROR MESSAGE REPLACED BATTERIES, BUT ERROR STILL OCCURRING NO PT'S INJURED. ABLE TO COMPLETE PROCEDURES PROBLEM STARTED ABOUT A MONTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |