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

Model Number	SDM-SYS-6000-2D
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the left side foot pedal switch for vertical travel was sticking intermittently.No injury reported.A field engineer was dispatched to the site and determined the foot pedal needed to be replaced.Once this was completed the system was working as intended.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Common Device Name: 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: 13695882
• Report Number: 1220984-2022-00012
• Device Sequence Number: 11718362
• Product Code: MUE
• UDI-Device Identifier: 15420045510753
• UDI-Public: (01)15420045510753(11)211111
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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
• Operator of Device: Health Professional
• Device Model Number: SDM-SYS-6000-2D
• Device Catalogue Number: SDM-SYS-6000-2D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown