MAUDE Adverse Event Report: HOLOGIC, INC SELENIA/LORAD MAMMOGRAM UNIT; FULL FIELD DIGITAL SYSTEM, XRAY, MAMMOGRAPHIC

Device Problems Device Displays Incorrect Message (2591); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2019

Event Type  malfunction  

Event Description

Patient underwent mammogram and machine stopped functioning during exam.An exposure and communication error was noted.Upon investigation, a cable was replaced and a loose connection was found.No patient harm.

• Brand Name: SELENIA/LORAD MAMMOGRAM UNIT
• Type of Device: FULL FIELD DIGITAL SYSTEM, XRAY, MAMMOGRAPHIC
• Manufacturer (Section D): HOLOGIC, INC
• MDR Report Key: 8343563
• MDR Text Key: 137120754
• Report Number: MW5084103
• 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: Other
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• 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: 53 YR