MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q BIPLANE; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 12/15/2017

Event Type  malfunction  

Event Description

During a endovascular coiling case an error popped up on the siemens artis q ipp 9 screen stating a plan tube overheating.We discovered our mechanical room was at 102 degrees fahrenheit.Plant ops was contacted to find the cause of the overheating issue.After a nearly 45 minute delay in procedure, clinical imaging discovered that all ir rooms were affected.The cause was due to a failure in the cooling system responsible for cooling the c-arms equipment rooms.I was informed by plant operations that they are running their backup process to cool the rooms.This has worked and procedures were continued.

• Brand Name: ARTIS Q BIPLANE
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 8273168
• MDR Text Key: 133949490
• Report Number: 8273168
• Device Sequence Number: 1
• Product Code: JAA
• 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: 01/03/2019

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: No Information
• 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: 01/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/24/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA