FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3171939
·
Received June 7, 2013
Report
- Report Number
- 1720753-2013-06854
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- May 28, 2013
- Report Date
- June 7, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER CANCELLED THE SERVICE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT ALL THE IMAGES APPEARED TO BELONG TO THE PT, BUT WHEN YOU SELECTED THE IMAGE, IT WAS AN IMAGE THAT WAS FOR SOMEONE ELSE BUT THE NAME WAS CORRECT. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 253477 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |