FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041509
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02752
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE CUSTOMER CONTINUED TO MONITOR THE SYSTEM AND REPORTED TO THE GE REPRESENTATIVE SEVERAL DAYS LATER THAT THE SYSTEM CONTINUES TO OPERATE AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM MAKES A CONTINUOUS BEEPING SOUND, THE MONITORS DON'T TURN ON, AND THE SYSTEM WILL NOT BOOT UP. 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 |