MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for SELENIA DIMENSIONS manufactured by Hologic, Inc..
[185014517]
3d mammography unit would not complete exposure on patient, error message received. Contacted support and message was dispatched to field engineer. Parts needed to be ordered and unit was down for two full days and one morning until almost around noon. All patients requesting tomosynthesis needed to be rescheduled. Total patients rescheduled: 134.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882656 |
| MDR Report Key | 9882656 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-01-22 |
| Report Date | 2020-03-12 |
| Date Reported to FDA | 2020-03-12 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SELENIA DIMENSIONS |
| Generic Name | FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC |
| Product Code | MUE |
| Date Received | 2020-03-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 36 APPLE RIDGE RD DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |