FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1820063
·
Received August 23, 2010
Report
- Report Number
- 1720753-2010-02714
- Event Type
- Malfunction
- Date Received
- August 23, 2010
- Date of Event
- July 14, 2010
- Report Date
- August 23, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND RESEATED CINE BRIDGE BOARD AND CABLES TO CINE BRIDGE AND CINE DRIVE. REFORMATTED CINE DRIVE. COMPLETED ALL TEST AND CHECKS. CINE OPERATION IS WORKING AS DESIGNED. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYSTEM IS LOCKING UP AND DISPLAYING A CINE DISK ERROR. 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 |