FDA Adverse Event
Malfunction
Summary report: N
SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D
MDR report key: 15701220
·
Received October 31, 2022
Report
- Report Number
- 1220984-2022-00089
- Event Type
- Malfunction
- Date Received
- October 31, 2022
- Date of Event
- October 6, 2022
- Report Date
- October 31, 2022
- Manufacturer
- HOLOGIC, INC
- Product Code
- MUE
- PMA / PMN Number
- P010025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 0
IT WAS REPORTED ON (B)(6) 2022 THAT DURING A SELENIA PROCEDURE INTERMITTENTLY WHEN THEY ATTEMPT TO MOVE THE C-ARM TO THE RIGHT HAND OBLIQUE POSITION THAT THE C-ARM WILL CONTINUE ROTATION TO THE MLO OR EVEN 360 POSITION EVEN AFTER IT HAS BEEN RELEASED. A FIELD ENGINEER EXAMINED THE CONSOLE AND DETERMINED THAT BOTH SWITCHES REQUIRED TO BE REPLACED. VERIFIED ALL BUTTONS WORKED WITHOUT ISSUES. THE SYSTEM MET THE MANUFACTURER´S SPECIFICATIONS. NO HARM TO THE PATIENT REPORTED. NO OTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2950828 | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D | FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | MUE | HOLOGIC, INC | SDM-00001-2D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |