MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-20 for SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM SDM-00001-2D manufactured by Hologic, Inc.
[182233330]
It was reported that the c-arm was turning by itself. As indicated, when they are positioning/rotating the c-arm, the first 45 degrees in either direction is fine; however when they go for the next 45 degrees, the c-arm doesn't stop, but keeps on going, turning completely upside down. No injury reported. A field engineer was dispatched to the site and determined the right hand gantry rotation switch needed to be replaced. Once this was completed the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2020-00026 |
| MDR Report Key | 9733080 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-20 |
| Date of Report | 2020-01-31 |
| Date Mfgr Received | 2020-01-31 |
| Device Manufacturer Date | 2011-10-01 |
| Date Added to Maude | 2020-02-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 SYSTEM |
| Generic Name | FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Product Code | MUE |
| Date Received | 2020-02-20 |
| Model Number | SDM-00001-2D |
| Catalog Number | SDM-00001-2D |
| 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 | 2020-02-20 |