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 2019-02-15 for MULTICARE PLATINUM RM-8-004-0017 manufactured by Hologic, Inc.
[138791048]
It was reported that the table will motor down on it's own intermittently. No injury reported. A field engineer was dispatched to the site. It was determined that the power control and lockout relay boards needed to be replaced and shielding was added to the through table cabling. Once this was completed the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220984-2019-00014 |
| MDR Report Key | 8345142 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-15 |
| Date of Report | 2019-01-18 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2019-02-15 |
| 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 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 | MULTICARE PLATINUM |
| Generic Name | STEREOTACTIC BREAST BIOPSY SYSTEM |
| Product Code | IZH |
| Date Received | 2019-02-15 |
| Model Number | RM-8-004-0017 |
| Catalog Number | RM-8-004-0017 |
| 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 | 2019-02-15 |