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

Model Number SDM-00001-M2D

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

It was reported that the rotation lever was sticky and the c-arm was rotating itself.No injury reported.A field engineer was dispatched to the site and determined the rotation switch 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
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 13934101
• MDR Text Key: 288107326
• Report Number: 1220984-2022-00021
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SDM-00001-M2D
• Device Catalogue Number: SDM-00001-M2D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1