FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2100786
·
Received May 12, 2011
Report
- Report Number
- 1720753-2011-07276
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 12, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE CUSTOMER HAD RESET A BREAKER. THE SERVICE REP FOUND A CUT IN A POWER CORD AND ORDERED A NEW POWER CORD ASSEMBLY, AND WILL BE REPLACED ON ANOTHER CASE. IT IS EXPECTED THAT THE SYSTEM WILL OPERATE AS INTENDED FOLLOWING THE REPAIR.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM TRIPPED A CIRCUIT BREAKER. NO PT 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 |