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

Model Number SEL-00007

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2019

Event Type  malfunction  

Manufacturer Narrative

As of today, the investigation is still in-process.A follow up will be filed as needed.

Event Description

It was reported that during patient positioning, the c-arm started an uncommanded rotation.The technologist hit the emergency stop button and no injury was reported.A field engineer has been onsite and the investigation is still in-process.

Event Description

It was determined that the left and right switch assemblies and the breast tray switch needed to be replaced.

• Brand Name: SELENIA MAMMOGRAPHY SYSTEM
• Type of Device: FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Manufacturer (Section D): HOLOGIC, INC; 36 & 37 apple ridge road; danbury CT 06810
• MDR Report Key: 8640627
• MDR Text Key: 146074420
• Report Number: 1220984-2019-00056
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 05/07/2019

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
• Device Operator: Health Professional
• Device Model Number: SEL-00007
• Device Catalogue Number: SEL-00007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/07/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1