FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2101810
·
Received May 10, 2011
Report
- Report Number
- 1720753-2011-07142
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 20, 2011
- Report Date
- May 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION AND THE REPORTED ERROR COULD NOT BE DUPLICATED. THE POWER AND GROUNDING CONNECTIONS WERE CHECKED AND TIGHTENED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN UNK ERROR MESSAGE THEN SHUT ITSELF OFF. UPON REBOOT, THE SYSTEM DISPLAYED A HIGH CAPACITY DISK ERROR MESSAGE WHICH OCCURRED OUTSIDE OF A PROCEDURE. 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 |