FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2152748
·
Received June 24, 2011
Report
- Report Number
- 1720753-2011-08511
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- June 15, 2011
- Report Date
- June 24, 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 ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE POWER SUPPLY VOLTAGE WAS LOW AND WAS ADJUSTED UP TO 5.15 VOLTS. THE NODES WERE FLASHED AND THE CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CHARGER ERROR MESSAGE, WOULD NOT PERFORM FLUOROSCOPY AND LOCKED UP. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |