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

Model Number SDM-00001-2D

Device Problem Unintended System Motion (1430)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

It was reported that the c-arm travels downward and does not stop when the button is released.No injury reported.A field engineer was dispatched to the site and determined the right and left footswitches needed to be replaced.Once this was completed the system was working as intended.

Manufacturer Narrative

The replaced parts were returned to hologic for investigation.The reported event could not be confirmed.The footswitch was functioning as per specification and a definitive root cause cannot be determined.Corrected data: section e1 was updated with the correct initial reporter information.

• Brand Name: SELENIA DIMENSIONS 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: 12372088
• MDR Text Key: 268299130
• Report Number: 1220984-2021-00034
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

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: SDM-00001-2D
• Device Catalogue Number: SDM-00001-2D
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1