FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2152946
·
Received June 17, 2011
Report
- Report Number
- 9617766-2011-01260
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 17, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PLUG TO THE FOOT SWITCH WAS DEFECTIVE. THE WIRING HARNESS TO THE BACKPLANE FOR THE HAND SWITCH AND THE FOOT SWITCH WAS REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S HAND AND FOOT SWITCH WOULD NOT RELEASE. NO PATIENT 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 (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |