MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-08 for 3DIMENSIONS 3DM-SYS-INTL3D manufactured by Hologic, Inc.
[178761623]
It was reported that the machine continues to drive down. No injury reported. A field engineer spoke with the customer and determined the footswitch down button was stuck. The customer "managed to free stuck switch" and the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2020-00002 |
| MDR Report Key | 9565622 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-19 |
| Date Mfgr Received | 2019-12-19 |
| Date Added to Maude | 2020-01-08 |
| 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 | 3DIMENSIONS |
| Generic Name | MAMMOGRAPHY SYSTEM |
| Product Code | OTE |
| Date Received | 2020-01-08 |
| Model Number | 3DM-SYS-INTL3D |
| Catalog Number | 3DM-SYS-INTL3D |
| 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 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-08 |