FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2043454
·
Received March 28, 2011
Report
- Report Number
- 1720753-2011-02914
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 9, 2011
- Report Date
- March 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CUSTOMER HAD EXCEEDED THE IMAGE ACQUISITION TIME. THE SERVICE ENGINEER DELETED IMAGES ON THE HARD DISK. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM FAILED TO SAVE PATIENT IMAGES. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |