FDA Adverse Event
Malfunction
Summary report: N
9800MD
MDR report key: 2043427
·
Received March 28, 2011
Report
- Report Number
- 1720753-2011-02904
- Event Type
- Malfunction
- Date Received
- March 28, 2011
- Date of Event
- March 4, 2011
- Report Date
- March 28, 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
THE CUSTOMER CANCELLED THE SERVICE CALL REQUEST. 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 REQUESTED A POWER SUPPLY BE ORDERED. NO REPORT OF PATIENT INJURY WAS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800MD | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |