FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1031049
·
Received April 17, 2008
Report
- Report Number
- 1720753-2008-20665
- Event Type
- Malfunction
- Date Received
- April 17, 2008
- Date of Event
- April 4, 2008
- Report Date
- April 14, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S BIOMED DETERMINED THE PROBLEMS WERE DUE TO THE MAINFRAME BATTERIES SO HE PURCHASED FROM PARTS SOURCE AND HAS REORDERED NEW BATTERIES. THE SERVICE CALL WAS CANCELLED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WAS GIVING LOW MA ERRORS. PT INVOLVED NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSOCPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |