FDA Adverse Event
Malfunction
Summary report: N
9400
MDR report key: 2041470
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02732
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 10, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE RESEATED THE PINS ON THE LEMO CONNECTOR, AND TIGHTENED THE PLUG ON THE INTERCONNECT CABLE. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE INTERCONNECT CABLE WAS BROKEN ON THE 9400 SYSTEM. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9400 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |