MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH MAMMOMAT REVELATION; FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC

Model Number 11343300

Device Problems Failure to Power Up (1476); Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 12/18/2020

Event Type  malfunction  

Event Description

When attempting a stereotactic biopsy, the biopsy needle was attached.When the tube head was moved back into position after attaching the needle, the machine stopped responding and kept showing error messages.Could not move tube head out of the way again to remove the biopsy needle.Had to use the compression paddle emergency release button to remove patient from the machine.After reboot and shut down the machine would not come back up.Patient had to be rescheduled to another day and siemens was called for an emergency service call.

• Brand Name: MAMMOMAT REVELATION
• Type of Device: FULL FIELD DIGITAL, SYSTEM, X-RAY, MAMMOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 11116283
• MDR Text Key: 225070666
• Report Number: 11116283
• Device Sequence Number: 1
• Product Code: MUE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11343300
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA