MULTICARE PLATINUM 8-004-0017

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-29 for MULTICARE PLATINUM 8-004-0017 manufactured by Hologic, Inc.

Event Text Entries

[178639396] It was reported that the table is moving up and down on its own and when the button is touched it jumps. No injury reported. A field engineer was dispatched to the site and determined the membrane keypad needed to be replaced. Once this was completed the system was working as intended.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1220984-2020-00012
• MDR Report Key: 9641359
• Report Source: USER FACILITY
• Date Received: 2020-01-29
• Date of Report: 2020-01-09
• Date of Event: 2020-01-09
• Date Mfgr Received: 2020-01-09
• Device Manufacturer Date: 2009-07-01
• Date Added to Maude: 2020-01-29
• 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

Device Details

• Brand Name: MULTICARE PLATINUM
• Generic Name: STEREOTACTIC BREAST BIOPSY SYSTEM
• Product Code: IZH
• Date Received: 2020-01-29
• Model Number: 8-004-0017
• Catalog Number: 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

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-01-29