MAUDE Adverse Event Report: HOLOGIC, INC. SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 2D

Model Number	SDM-00001-2D
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One of the footswitches that move the c-arm vertically had stuck.Both footswitches were replaced.
Event or Problem Description
C-arm lowered with patient in compression.The technologist was in the process of positioning the patient when the c-arm started to move down.The technologist moved the patient back out of the way.No injury to the patient.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 2D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 5680807
• Report Number: 1220984-2016-00010
• Device Sequence Number: 149077
• Product Code: OTE
• UDI-Device Identifier: 15420045500013
• UDI-Public: 15420045500013
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: PO80003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/24/2016

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: Medical Technologist
• Device Model Number: SDM-00001-2D
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1