FDA Adverse Event
Malfunction
Summary report: N
M-IV MAMMOGRAPHY SYSTEM
MDR report key: 271833
·
Received March 23, 2000
Report
- Report Number
- 1220984-2000-00006
- Event Type
- Malfunction
- Date Received
- March 23, 2000
- Date of Event
- January 1, 2000
- Report Date
- March 23, 2000
- Manufacturer
- TREX MEDICAL SYSTEMS CORP
- Product Code
- IZH
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE TECHNOLOGIST RELEASED FOOT FROM THE FOOT-SWITCH, THE C-ARM ROTATED FROM A -37 DEGREE ANGLE TO A -89 DEGREE ANGLE WITHOUT ACTUATION. THE PT HAD NOT BEEN FULLY COMPRESSED AND WAS ABLE TO MOVE AWAY FROM THE UNIT DURING ROTATION. THERE WAS NO PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | M-IV MAMMOGRAPHY SYSTEM | RADIOLOGIC | IZH | TREX MEDICAL SYSTEMS CORP | M-IV | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |