MAUDE Adverse Event Report: HOLOGIC, INC SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D

Model Number	SDM-00001-3D
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A design change was made to the ground strap in february 2018 to provide more strap flexibility.
Event or Problem Description
It was reported that a patient complained of a shock on the top of her breast during her mammogram.The patient was examined and there were no visible injuries and no medical intervention was required.The customer noted no issues except for the one patient.A field engineer was dispatched to the site and found that all ground wires were well seated and resistance measurements to ground at all exposed metal points were less than an ohm with the exception of the paddle shift assembly which measured 660 ohms.Measured all exposed metal to ground voltages and the highest readings were: 0.004vdc and 4.6 millivolts ac.All voltage measurements from nonconductive surfaces (paddles and breast tray) were zero.A broken ground wire was found inside the gantry and was replaced.As a precaution the external compression device, external compression device covers, large and small compression paddles, and the breast tray cover were also replaced.The field engineer followed up with the customer on (b)(6) 2019 and no further incidents were reported.The system is working as intended.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEMS, 3D
• Common Device Name: MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 9336750
• Report Number: 1220984-2019-00131
• Device Sequence Number: 19295270
• Product Code: OTE
• UDI-Device Identifier: 15420045505636
• UDI-Public: 15420045505636
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P080003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2019

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-00001-3D
• Device Catalogue Number: SDM-00001-3D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1