MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-13 for DIMENSIONS manufactured by Hologic, Inc..
[174739679]
Mammography unit malfunctioned during weekly quality control process. Contacted service to send a field engineer. Patients not able to be imaged until corrected. All 30 patients were contacted. Eight patients rescheduled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9581928 |
| MDR Report Key | 9581928 |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-23 |
| Date of Event | 2019-12-20 |
| Report Date | 2019-12-23 |
| Date Reported to FDA | 2019-12-23 |
| Date Reported to Mfgr | 2020-01-13 |
| Date Added to Maude | 2020-01-13 |
| 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 | DIMENSIONS |
| Generic Name | FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC |
| Product Code | MUE |
| Date Received | 2020-01-13 |
| 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 | 2020-01-13 |