FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2170962
·
Received June 30, 2011
Report
- Report Number
- 1720753-2011-08687
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 30, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION AND RESEATED THE CONNECTORS AND THE PRINTED CIRCUIT BOARDS. THE PS1 POWER SUPPLY WAS ADJUSTED AND THE PIN CONNECTOR WAS RESEATED. 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 WOULD BEEP AND NOT STOP BEEPING UNTIL IT WAS RE-BOOTED. 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 |