FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2043468
·
Received March 28, 2011
Report
- Report Number
- 1720753-2011-02921
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE IMAGE PROCESSING COMPUTER WAS REPLACED. ALSO, THE NETWORK WAS UPDATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM SHUT DOWN AND THEN FAILED TO BOOT UP. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |