FDA Adverse Event
Malfunction
Summary report: N
PROTEUS
MDR report key: 2954115
·
Received November 7, 2007
Report
- Report Number
- 9613445-2007-00020
- Event Type
- Malfunction
- Date Received
- November 7, 2007
- Date of Event
- November 24, 2004
- Report Date
- November 24, 2004
- Manufacturer
- GE HANGWEI MEDICAL SYSTEMS CO., LTD.
- Product Code
- KPR
- PMA / PMN Number
- K993090
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN AN OPERATOR DROVE THE PROTEUS TABLE DOWN, HER FOOT WAS CAUGHT BETWEEN THE FOOT PEDAL AND THE OUTER SKIN OF THE TELESCOPIC COVERS. NO INJURY WAS REPORTED. THE CONCERN IS FOR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEUS | KPR | GE HANGWEI MEDICAL SYSTEMS CO., LTD. | 2259988 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |