FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3000942
·
Received February 27, 2013
Report
- Report Number
- 1720753-2013-03197
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- February 20, 2013
- Report Date
- February 27, 2013
- 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 REP PERFORMED AN ON SITE INVESTIGATION. THE WORK STATION BOARDS AND CONNECTORS WERE RESEATED AND THE POWER SUPPLY VOLTAGE WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED COMMUNICATION FAILURE ERROR MESSAGES DURING PROCEDURES. THIS ERROR MESSAGE WILL LIKELY CAUSE THE SYSTEM TO LOCK UP OR SHUT DOWN. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83585 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |