MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-03 for SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM SDM-00001-2D manufactured by Hologic, Inc.
[178762023]
As of today the investigation is still in process and a follow up will be filed as needed.
Patient Sequence No: 1, Text Type: N, H10
[178762024]
It was reported that the gantry will not go up or down and it's reading "vertical/rotational e-stop engaged" when it is not. Machine was also producing a pmc 38:27 error code. No injury reported. A field engineer was dispatched to the site and determined a third party service company was working on the motion error and during repairs they wired the c-arm vertical limit switch backwards. The vta drive was jammed at the drive nut. The vertical limit switch was rewired correctly and the vertical drive nut, worm gear, and stops and mountings were replaced. Once this was completed the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2020-00001 |
| MDR Report Key | 9547218 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-03 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2019-12-06 |
| Device Manufacturer Date | 2014-03-01 |
| Date Added to Maude | 2020-01-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KRISTIN FORNIERI |
| Manufacturer Street | 36 & 37 APPLE RIDGE ROAD |
| Manufacturer City | DANBURY CT 06810 |
| Manufacturer Country | US |
| Manufacturer Postal | 06810 |
| Manufacturer Phone | 2037318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM |
| Generic Name | FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Product Code | MUE |
| Date Received | 2020-01-03 |
| Model Number | SDM-00001-2D |
| Catalog Number | SDM-00001-2D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC |
| Manufacturer Address | 36 & 37 APPLE RIDGE ROAD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |