FDA Adverse Event
Malfunction
Summary report: N
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
MDR report key: 7772193
·
Received August 10, 2018
Report
- Report Number
- 1220984-2018-00131
- Event Type
- Malfunction
- Date Received
- August 10, 2018
- Date of Event
- July 19, 2018
- Report Date
- July 19, 2018
- Manufacturer
- HOLOGIC, INC
- Product Code
- OTE
- UDI-DI
- 15420045505582
- PMA / PMN Number
- P080003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE C-ARM ROTATIONAL ISSUE OF CONTINUED ROTATION PASSED THE INTENDED STOP POSITION HAD REOCCURRED. SEE ASSOCIATED MEDWATCH, MANUFACTURER'S REPORT # 122984-2018-00128. A FIELD ENGINEER WAS DISPATCHED TO THE SITE AND WAS UNABLE TO REPRODUCE THE REPORTED ISSUE. THE C-ARM DEFAULT POSITIONS, CRM SOFTWARE, AND CALIBRATION DATA WERE RELOADED. THE SYSTEM WAS WORKING AS INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615468 | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D | MAMMOGRAPHY SYSTEM | OTE | HOLOGIC, INC | SDM-00001-3D | 15420045505582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |