MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH SOMATOM EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2021

Event Type  malfunction  

Event Description

Scanner had normal qa procedures on morning of procedure and was up and running properly.Patient was brought into the room, the procedure began, and mid procedure, with the biopsy needle was in position by md, the scanner shutdown unpredictably.The scanner was rebooted and then md was able to continue and completed patients procedure.Radiology engineers were notified, and manufacturer team notified also.This was the second occurrence of this malfunction within 2 weeks.

• Brand Name: SOMATOM EDGE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 11874968
• MDR Text Key: 252396584
• Report Number: 11874968
• Device Sequence Number: 1
• Product Code: JAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2021

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA