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

Device Problems Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/15/2019

Event Type  malfunction  

Event Description

Patient undergoing mammography when the machine stopped working.Processing error.Machine rebooted and computer replaced.Fda safety report id # (b)(4).

• Brand Name: HOLOGIC SELENIA
• Type of Device: FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): HOLOGIC, INC.
• MDR Report Key: 8944819
• MDR Text Key: 156289538
• Report Number: MW5089430
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/27/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2019
• 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: 56 YR