MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D; FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM

Model Number SDM-05000-2D2

Device Problem Unintended System Motion (1430)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, during a selenia dimensions procedure the c-arm moved from 45 to 90 degrees intermittently.A field engineer examined the equipment and confirmed that the c-arm rotates intermittently.The field engineer replaced the c-arm switch banks and foot switches and tested the equipment.The system met the manufacturer´s specifications.No patient or staff injury reported.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 2D
• Type of Device: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer (Section G): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: daniel guevara ; 562 parkway; coyol free zone building b24; san jose 20102 ; CR 20102
• MDR Report Key: 17126854
• MDR Text Key: 317250581
• Report Number: 1220984-2023-00048
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/14/2023

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-05000-2D2
• Device Catalogue Number: SDM-05000-2D2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2011
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1