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

Model Number SDM-00001-2D

Device Problem Unintended System Motion (1430)

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

Event Date 04/17/2023

Event Type  malfunction  

Event Description

It was reported on april 17th that the c-arm experienced uncommanded c-arm motion.A field engineer examined the equipment and could not reproduce the issue since none of the rotational switches showed any issues.But logs showed that the right switch bank was stuck so he replaced it.Both bank switches were replaced and the system met the manufacturer´s specifications.No injury to the patient nor staff.No other information is available.

• 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; ma; 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: 16882151
• MDR Text Key: 314944369
• Report Number: 1220984-2023-00042
• Device Sequence Number: 1
• Product Code: MUE
• UDI-Device Identifier: 15420045510623
• UDI-Public: (01)15420045510623(11)160824
• 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: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• 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: 04/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1