FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 1880044
·
Received October 13, 2010
Report
- Report Number
- 1720753-2010-03547
- Event Type
- Malfunction
- Date Received
- October 13, 2010
- Date of Event
- September 29, 2010
- Report Date
- October 13, 2010
- 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 REP EVALUATED THE SYSTEM AND FOUND THAT THE MONOBLOCK NEEDED TO BE REPLACED. REPLACED THE CPU BATTERY AND THE MONOBLOCK. FOUND THAT THE HARD DRIVE SHOCK MOUNTS ARE DRY ROTTED AND REPLACED THEM. PERFORMED A BEAM ALIGNMENT AND CAMERA ALIGNMENT. SYSTEM IS OPERATING AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THAT INTERMITTENTLY, THE SYSTEM WOULD LOCK UP AND A BUZZER WOULD SOUND. CUSTOMER WOULD HAVE TO REBOOT THE SYSTEM TO CLEAR THE ISSUE. NO PT INJURY TO REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |