FDA Adverse Event
Malfunction
Summary report: N
COMPAX 40E
MDR report key: 1162224
·
Received September 16, 2008
Report
- Report Number
- 2126677-2008-00069
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- March 10, 2008
- Report Date
- March 10, 2008
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- IZZ
- PMA / PMN Number
- K884930
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE FIELD ENGINEER (FE) FOUND A BROKEN WIRE THAT PREVENTED THE LATERAL LOCKS FROM ENGAGING. THE FE REPLACED THE CABLE ASSEMBLIES 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 ACTIVATE CAUSING FREE TABLETOP MOTION IN THE LATERAL DIRECTION WITH NO RESISTANCE. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING A PATIENT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPAX 40E | IZZ | GE MEDICAL SYSTEMS, LLC | 2142182 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |