FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2150939
·
Received June 21, 2011
Report
- Report Number
- 1720753-2011-08382
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CB2 WAS TRIPPING DURING HIGH POWER SHOTS SO THE SURGE SUPPRESSOR PRINTED CIRCUIT BOARD WAS REPLACED. THE POWER CORD ASSEMBLY AND THE LINE FILTER 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 DURING A CASE THE SYSTEM SHUT DOWN AND WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |