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

Model Number SDM-05000-3D3

Device Problems Poor Quality Image (1408); Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 10/04/2017

Event Type  malfunction  

Event Description

It was reported that they are getting intermittent line artifacts in the images, causing the patient to be re-exposed.It was determined that the array needed to be replaced once this was replaced the unit is working as intended.

• Brand Name: SELENIA DIMENSIONS MAMMOGRAPHY SYSTEM 3D
• Type of Device: 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
• MDR Report Key: 6997494
• MDR Text Key: 91453950
• Report Number: 1220984-2017-00126
• Device Sequence Number: 1
• Product Code: OTE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PO80003
• 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: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: SDM-05000-3D3
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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