MAUDE Adverse Event Report: HOLOGIC, INC. MAMMOGRAM MACHINE; FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number SELENIA

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 06/28/2021

Event Type  malfunction  

Event Description

Mammography imaging was being performed when a generic error code during exposure occurred.This resulted in suboptimal imaging.Imaging was repeated.Issue has been sporadic with machine.Taken out of service part ordered.Fda safety report id # (b)(4).

• Brand Name: MAMMOGRAM MACHINE
• Type of Device: FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 12137385
• MDR Text Key: 260804085
• Report Number: MW5102378
• Device Sequence Number: 1
• Product Code: MUE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SELENIA
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR