FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041556
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02784
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 3, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PARTS HAVE BEEN REQUESTED BY THE FIELD SERVICE ENGINEER. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PATIENT OR STAFF INJURY WAS REPORTED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE FUSE BLEW AND THE MONITOR WAS BLANK ON THE 9900 SYSTEM. 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 |