FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3014303
·
Received March 6, 2013
Report
- Report Number
- 1720753-2013-03438
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 25, 2013
- Report Date
- March 6, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM BATTERIES WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THEY HAD TO REBOOT THE SYSTEM. A CHARGER FAILED ERROR MESSAGE HAD OCCURRED. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96539 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |