FDA Adverse Event
Malfunction
Summary report: N
DEFINLUM 8000
MDR report key: 2954117
·
Received November 7, 2007
Report
- Report Number
- 9613445-2007-00021
- Event Type
- Malfunction
- Date Received
- November 7, 2007
- Date of Event
- October 17, 2007
- Report Date
- October 17, 2007
- Manufacturer
- GE HANGWEI MEDICAL SYSTEMS CO., LTD.
- Product Code
- IZF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO EVENT REPORTED FOR THE DEFINLUM 8000 X-RAY SYSTEM, THEREFORE, NO PATIENT WAS INVOLVED. INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
IT WAS PREVIOUSLY REPORTED THAT THE PROTEUS XR/A TABLE DROVE PAST THE LOWER LIMIT SAFETY SWITCHES. THE DEFINLUM 8000 TABLE CIRCUIT BOARD HAS SIMILAR TECHNOLOGY, THEREFORE, CREATING A SIMILAR INJURY PROSPECTUS. NO INJURY WAS REPORTED. THE CONCERN IS FOR A TOE PINCH HAZARD, IF THE OPERATOR'S FOOT WOULD BECOME TRAPPED BETWEEN THE OUTER COVERS AND THE FLOOR OR OPERATING PEDALS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEFINLUM 8000 | IZF | GE HANGWEI MEDICAL SYSTEMS CO., LTD. | 5131070 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |