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

Model Number SEL-00013

Device Problems Device Operates Differently Than Expected (2913); Unintended Movement (3026)

Patient Problem Not Applicable (3189)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

No parts replaced and no field engineer dispatch required.Technical support was able to assist the customer over the phone to troubleshoot and resolve the issue of unintended movement and frozen system.Customer follow-up call made on 6/26/2018 and per the technologist the issue had not reoccurred.(b)(4).

Event Description

It was reported that the technologist was positioning the patient who was standing.The c-arm height was adjusted and when the footswitch was released the c-arm continued moving in a downward motion.The system was then frozen and would not move at all.No injury was reported.Technical support assisted the customer to do a full shutdown/reboot of the system.Once this was completed, the system was working as intended.

• 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
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, CT 06810 ; 2037318491
• MDR Report Key: 7650828
• MDR Text Key: 113008590
• Report Number: 1220984-2018-00108
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: SEL-00013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2009
• 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