FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3001874
·
Received February 12, 2013
Report
- Report Number
- 1720753-2013-01691
- Event Type
- Malfunction
- Date Received
- February 12, 2013
- Date of Event
- February 1, 2013
- Report Date
- February 12, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE BATTERIES WERE IDENTIFIED AS REQUIRING REPLACEMENT. THE CUSTOMER OPTED TO REPLACE THE BATTERIES THEMSELVES. AFTER THE BATTERIES WERE REPLACED, THE SERVICE REPRESENTATIVE VERIFIED THAT THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A POWER VOLTAGE ERROR MESSAGE AND WOULD NOT BOOT UP. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 61345 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |