FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2090586
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06537
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 29, 2011
- Report Date
- April 26, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE BATTERIES AND THE BROKEN HANDLE WERE REPLACED. THE VOLTAGE WAS FOUND TO BE MEETING SPECIFICATIONS. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9600 SYSTEM IS DOWN. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |