MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-18 for SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D SDM-SYS-6000-3D manufactured by Hologic, Inc.
[182233274]
It was reported that the c-arm was moving on its own. No injury reported. A field engineer was dispatched to the site and determined the rotation switch on the back of the detector needed to be replaced. Once this was completed the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2020-00024 |
| MDR Report Key | 9720377 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Date Added to Maude | 2020-02-18 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 7318491 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D |
| Generic Name | MAMMOGRAPHY SYSTEM |
| Product Code | OTE |
| Date Received | 2020-02-18 |
| Model Number | SDM-SYS-6000-3D |
| Catalog Number | SDM-SYS-6000-3D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |