FDA Adverse Event
Malfunction
Summary report: N
DEFINIUM 8000
MDR report key: 1112844
·
Received August 13, 2008
Report
- Report Number
- 2126677-2008-00058
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 1, 2008
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- KPR
- PMA / PMN Number
- K051967
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE FIELD ENGINEER (FE) INSPECTED THE UNIT, AND FOUND THAT THE I/O BOARD AND RELATED CABLES WERE DEFECTIVE. THE FE REPLACED THE BOARD, THE CABLES AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO MOVE IN TWO DIRECTIONS WITHOUT RESISTANCE. THERE WAS NO INJURY REPORTED. THE ISSUE WAS DISCOVERED AS THE OPERATOR WAS SETTING UP A PT. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEFINIUM 8000 | KPR/IZF/MQB | KPR | GE MEDICAL SYSTEMS, LLC | 5131070 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |