FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2021861
·
Received February 25, 2011
Report
- Report Number
- 1720753-2011-01688
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 25, 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
THE GE REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY PACKS WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED WHILE IN THE CARDIAC FUNCTION THE SYSTEM FREEZES EACH TIME THE X-RAY BUTTON IS PRESSED FOR A SECOND TIME. THE SYSTEM DISPLAYS REGULATION FAILED AND CHARGE FAILED MESSAGES. THE SYSTEM RESTARTED AFTER SWITCHING THE SYSTEM OFF AND BACK ON. NO REPORT OF PT 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 |