FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2022249
·
Received February 28, 2011
Report
- Report Number
- 1720753-2011-01716
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE REPRESENTATIVE REMOVED AND REPLACED THE BATTERY CHARGER BOARD. ALSO, THE BATTERY CHARGER OUTPUT WAS ADJUSTED. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9800 SYSTEM DISPLAYED LOW MA AND CHARGER FAILURE ERROR MESSAGES. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPY X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |