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

Model Number SDM-05000-2D2

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Not Applicable (3189)

Event Date 12/04/2017

Event Type  malfunction  

Event Description

It was reported that they were getting intermittent errors,and white monitors, which causes the patient to be re-exposed.They determined that the video card needed to be replaced.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM
• Type of Device: FULL FILED DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC.; 36 & 37 apple ridge road; danbury CT 06810
• Manufacturer Contact: debra rosenberg ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2032074512
• MDR Report Key: 7158018
• MDR Text Key: 96225287
• Report Number: 1220984-2018-00002
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO10025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 12/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: SDM-05000-2D2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1