MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-11 for 3DIMENSIONS 3DM-SYS-STD manufactured by Hologic, Inc.
[183261235]
As of today the investigation is still in process and a follow up will be filed as needed.
Patient Sequence No: 1, Text Type: N, H10
[183261236]
It was reported that when using the fingerprint scanner an electrical shock was felt by two technologists. No injury reported. A field engineer was dispatched to the site and was not able to confirm the reported issue. No voltage was measured from the fingerprint scanner. The assembly, which included the emergency stop button and fingerprint scanner was replaced. Per the customer, there has been no further reported issues since the repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2020-00037 |
| MDR Report Key | 9820256 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-11 |
| Date of Report | 2020-02-17 |
| Date Mfgr Received | 2020-02-17 |
| Date Added to Maude | 2020-03-11 |
| 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 | 3DIMENSIONS |
| Generic Name | MAMMOGRAPHY SYSTEM |
| Product Code | OTE |
| Date Received | 2020-03-11 |
| Model Number | 3DM-SYS-STD |
| Catalog Number | 3DM-SYS-STD |
| 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 | 2020-03-11 |