FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3770249
·
Received March 10, 2014
Report
- Report Number
- 1720753-2014-02148
- Event Type
- Malfunction
- Date Received
- March 10, 2014
- Date of Event
- February 28, 2014
- Report Date
- March 10, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED A DISPLAYED COMMUNICATION ERROR. A COMMUNICATION FAILURE ERROR MESSAGE WILL LIKELY RESULT IN A SYSTEM LOCKUP, NO BOOT, OR SHUT DOWN SITUATION. THERE ARE NO REPORT OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143635 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |