FDA Adverse Event
Malfunction
Summary report: N
9400
MDR report key: 3182466
·
Received June 14, 2013
Report
- Report Number
- 1720753-2013-07153
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 23, 2013
- Report Date
- June 14, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY PACK NEEDS TO BE REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THE SYS FAILED OT DISPLAY AN IMAGE AND SHUT DOWN WITHOUT COMMAND. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272116 | 9400 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |