MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH SIEMENS ARTIS Q.ZEN R/F SYSTEM; SYSTEM, X-RAY, ANGIOGRAPHIC

Device Problems Device Emits Odor (1425); Unexpected Shutdown (4019); Intermittent Energy Output (4025)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/10/2023

Event Type  Injury  

Event Description

During a watchman left atrial closure device case, the x-ray system shutdown due to unknown reasons.Prior to this the x-ray was working routinely, no error codes, not indications of issues, and was working for 30min during the procedure.This incident happened just as the device was being inserted into the patient for deployment.The case was aborted and the patients access site was closed, then he was awaken and taken to the recovery area.Ias-a computer had a burnt electronics smell and was shut down.

• Brand Name: SIEMENS ARTIS Q.ZEN R/F SYSTEM
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 16833000
• MDR Text Key: 314300969
• Report Number: MW5117120
• Device Sequence Number: 1
• Product Code: IZI
• 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: 04/25/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male