FDA Adverse Event
Malfunction
Summary report: N
9600EMI
MDR report key: 1071033
·
Received July 10, 2008
Report
- Report Number
- 1720753-2008-22759
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- June 11, 2008
- Report Date
- June 20, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE BOOT-UP OF WORKSTATION WAS OK. INSPECTION OF "C" LEMO CONNECTOR FOUND 1 PIN PUSHED IN AND 2 APPARENTLY MISSING. INTERCONNECT PLUG DISASSEMBLED, LOCKING PHLANGE BROKEN, 1 WIRE FOUND BROKEN INSIDE. PARTS ORDERED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WILL NOT BOOT UP AND THE SCREENS ON MONITORS HAVE A WHITE BLOCK. THE MONITORS ARE FLASHING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600EMI | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |