FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2023062
·
Received February 24, 2011
Report
- Report Number
- 1720753-2011-01620
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 9, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP PERFORMED AN ON SITE INVESTIGATION. THE CONNECTIONS AND FUSES ON THE POWER SIGNAL INTERFACE WERE RESEATED AND THE VOLTAGE TO THE POWER SUPPLY WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE SYSTEM DISPLAYED A COMMUNICATION ERROR MESSAGE. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |