FDA Adverse Event
Malfunction
Summary report: N
PROTEUS XR/A
MDR report key: 2954104
·
Received November 15, 2007
Report
- Report Number
- 9613445-2007-00023
- Event Type
- Malfunction
- Date Received
- November 15, 2007
- Date of Event
- October 23, 2007
- Report Date
- October 30, 2007
- Manufacturer
- GE HANGWEI MEDICAL SYSTEMS CO., LTD.
- Product Code
- KPR
- PMA / PMN Number
- K993090
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
GE FIELD ENGINEER ADJUSTED THE LOWER LIMIT FOR THE TABLE TO MAKE SURE THAT THE TRIM COVER WILL NOT TRAP AN OPERATOR'S TOE AT THIS SITE. ATTEMPTS TO OBTAIN PT INFO WAS UNSUCCESSFUL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE X-RAY TABLE WAS LOWERED, THE TECHNICIAN'S FOOT WAS TRAPPED BETWEEN THE FOOT PEDALS AND TABLE TRIM COVER. THE CONCERN IS FOR SERIOUS INJURY DUE TO A POTENTIAL PINCH POINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEUS XR/A | KPR | GE HANGWEI MEDICAL SYSTEMS CO., LTD. | 2259988 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |