FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2102743
·
Received May 23, 2011
Report
- Report Number
- 1720753-2011-07537
- Event Type
- Malfunction
- Date Received
- May 23, 2011
- Date of Event
- May 11, 2011
- Report Date
- May 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PS1 POWER SUPPLY IN THE MAINFRAME WAS INCREASED FROM 4.8 VDC TO 5.25 VDC ON THE GENERATOR INTERFACE PRINTED CIRCUIT BOARD. 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 DURING A PROCEDURE, THE SYSTEM DISPLAYED CONTROL PANEL AND COMMUNICATION ERROR MESSAGES. NO PT 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 |