FDA Adverse Event
Malfunction
Summary report: N
LIGHTSPEED QX/I TABLE
MDR report key: 274494
·
Received April 17, 2000
Report
- Report Number
- 2183289-2000-00001
- Event Type
- Malfunction
- Date Received
- April 17, 2000
- Date of Event
- March 19, 2000
- Report Date
- April 17, 2000
- Manufacturer
- GE MEDICAL SYSTEMS
- Product Code
- JAK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED TO GE THAT THE GANTRY ON A NEWLY INSTALLED QX/I TILTED BACK WITHOUT OPERATOR COMMAND. THE GANTRY TILTED BACK IN 5 DEGREE INCREMENTS UNTIL IT STOPPED AT THE FIRMWARE LIMIT. THIS EVENT WAS FIRST OBSERVED BY A TECHNOLOGIST AND THEN BY THE FIELD ENGINEER CALLED IN TO TROUBLESHOOT. THIS HAPPENED PRIOR TO FIRST PT USE. NO INJURY OR DAMAGE OCCURRED. THE EVENT WAS CAUSED BY CIRCUIT BOARD FAILURE. THE BOARD WAS REPLACED AND THE EVENT HAS NOT RECURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIGHTSPEED QX/I TABLE | COMPUTED TOMOGRAPHY | JAK | GE MEDICAL SYSTEMS | 2225283 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |