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

Model Number SEL-00014

Device Problems Unintended Movement (3026); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2020

Event Type  malfunction  

Event Description

It was reported that the c-arm has begun to drift downwards without noise or errors.No injury reported.A field engineer was dispatched to the site and was not able to reproduce the reported issue of drifting downwards.The customer also reported that there was noise using the c-arm rotation and the field engineered cleaned the stereoloc brake plate to resolve this issue.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: 9683759
• MDR Text Key: 182562339
• Report Number: 1220984-2020-00017
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEL-00014
• Device Catalogue Number: SEL-00014
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1