MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number SDM-00001-2D

Device Problem Unintended System Motion (1430)

Patient Problem Bruise/Contusion (1754)

Event Date 01/13/2020

Event Type  malfunction  

Manufacturer Narrative

As of today the investigation is still in process and a follow up will be filed as needed.

Event Description

It was reported that while a patient was in compression the c-arm rotated.The customer reported the patient had a bruised breast the next day.A field engineer was dispatched to the site.

Event Description

It was determined that the rear rotation switch, lateral rotation switch, and power distribution drawer needed to be replaced.Once this was completed the system was working as intended.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Type of Device: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 9661243
• MDR Text Key: 178629357
• Report Number: 1220984-2020-00015
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SDM-00001-2D
• Device Catalogue Number: SDM-00001-2D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1