FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2193055
·
Received July 22, 2011
Report
- Report Number
- 1720753-2011-20317
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP TIGHTENED THE SCREWS AT THE HUBBLE CONNECTOR. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP, THE WORKSTATION WOULD LOSE POWER, AND LOOSE SCREWS WERE FOUND ON THE HUBBLE CONNECTOR. 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 |