FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2092817
·
Received May 5, 2011
Report
- Report Number
- 9617766-2011-01003
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 5, 2011
- Report Date
- May 5, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CONNECTOR CABLE AND THE PS1 POWER SUPPLY WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS PRODUCING X-RAYS INDEPENDENTLY. 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 |