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 10/11/2021

Event Type  malfunction  

Event Description

It was reported that the "gantry moving on its own accord" in a downward direction.No injury reported.A field engineer was dispatched to the site and determined the right foot 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
• MDR Report Key: 12730111
• MDR Text Key: 282496426
• Report Number: 1220984-2021-00048
• 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: foreign,user facility
• Type of Report: Initial
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 10/11/2021
• Initial Date FDA Received: 11/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2013
• 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