FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2241100
·
Received August 17, 2011
Report
- Report Number
- 1720753-2011-21134
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 4, 2011
- Report Date
- August 17, 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 REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CABLES AND PRINTED CIRCUIT BOARDS WERE RESEATED, AND THE RIBBON CABLE WAS MOVED WHICH DUPLICATED THE ISSUE. THE CABLE ON THE CONNECTOR WAS RESEATED, HOWEVER, THE CONNECTOR LOCK WAS MISSING SO A NEW CABLE WAS ORDERED FOR THE CUSTOMER TO INSTALL. 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 THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE WHEN FLUOROSCOPIC X-RAY WAS ATTEMPTED, THEN SHUT DOWN UNCOMMANDED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |