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

Model Number	SDM-00001-2D
Medical Device Problem Codes	Collapse (1099); Shielding Failure (1568)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	06/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the glass operator shield shattered after business hours.There was no injury reported and no one was near the shield at the time.A field engineer was dispatched to the site and the shield was replaced.

• 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
• MDR Report Key: 7654491
• Report Number: 1220984-2018-00111
• Device Sequence Number: 19109596
• Product Code: MUE
• UDI-Device Identifier: 15420045505582
• UDI-Public: 15420045505582
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P010025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date (Section B): 06/06/2018

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: Device Unattended
• Device Model Number: SDM-00001-2D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 07/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1