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

Model Number SEL-00019

Device Problem Unintended System Motion (1430)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

Capa(b)(4).

Event Description

It was reported that when the c-arm is commanded to move downward, with the footswitch, it does not stop when the switch is released.No injury reported.A field engineer was dispatched to the site and determined the left footswitch needed to be replaced.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
• Manufacturer Contact: kristin fornieri ; 36 & 37 apple ridge road; danbury, ct ; 7318491
• MDR Report Key: 10009001
• MDR Text Key: 189453723
• Report Number: 1220984-2020-00051
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

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
• Device Operator: Health Professional
• Device Model Number: SEL-00019
• Device Catalogue Number: SEL-00019
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 04/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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