FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2101623
·
Received May 11, 2011
Report
- Report Number
- 1720753-2011-07214
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 22, 2011
- Report Date
- May 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PS1 POWER SUPPLY WAS ADJUSTED AND THE GENERATOR INTERFACE PRINTED CIRCUIT BOARD WAS REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS EVENT MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A CONNECTION ERROR MESSAGE DISPLAYED THAT THERE WAS NO COMMUNICATION BETWEEN THE C-ARM AND THE MONITOR CART, AND WHEN RELEASING THE EXPOSURE BUTTON, THE SYSTEM CONTINUED TO EXPOSE. THIS HAPPENED DURING A CASE. 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 |