FDA Adverse Event
Malfunction
Summary report: N
RTE
MDR report key: 1191926
·
Received October 1, 2008
Report
- Report Number
- 2126677-2008-00077
- Event Type
- Malfunction
- Date Received
- October 1, 2008
- Date of Event
- February 11, 2008
- Report Date
- February 11, 2008
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- KPR
- PMA / PMN Number
- K813173
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE FIELD ENGINEER (FE) FOUND A STUCK FOOT PEDAL THAT PREVENTED THE LOCKS FROM ENGAGING. THE FE FIXED THE FOOT PEDAL, AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH DIRECTIONS WITHOUT RESISTANCE. THERE WAS NO INJURY REPORTED. 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 | RTE | KPR | GE MEDICAL SYSTEMS, LLC | 46-216697P3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |