FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1070168
·
Received July 9, 2008
Report
- Report Number
- 1720753-2008-20474
- Event Type
- Malfunction
- Date Received
- July 9, 2008
- Date of Event
- March 31, 2008
- Report Date
- April 4, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ONE TECH COMPLAINED 9900 TOOK TOO LONG TO BOOT UP, THE OTHER TECH HAS BEEN USING THE MACHINE FOR 2 DAYS WITHOUT ANY ISSUES, SHE CANCELLED THE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM BOOT UP, TECH ENTERED PT INFO, THEN SYSTEM REBOOTED ON IT'S OWN. MACHINE TAKEN OUT OF SERVICE. NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |