FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2040379
·
Received February 15, 2011
Report
- Report Number
- 1720753-2011-02250
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- February 18, 2011
- Report Date
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED AND THE POWER CABLE WAS REPAIRED. THE SYS OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WERE EXPOSED WIRES ON THE POWER CORD OF THE 9800 SYS AND THAT THE INTERCONNECT CABLE APPEARED TO HAVE BEEN CUT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |