FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2081030
·
Received April 14, 2011
Report
- Report Number
- 9617766-2011-00907
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 23, 2011
- Report Date
- April 14, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. FLUOROSCOPIC IMAGES WERE ABLE TO BE SAVED, BUT WERE NOT RECEIVED BY THE PACS SYSTEM. NO OTHER REPAIR INFO IS AVAILABLE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 8800 SYSTEM WOULD NOT SAVE IMAGES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |