MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC ARTIS ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Device Problems Fluid/Blood Leak (1250); Overheating of Device (1437); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Event Description

Problem with laird water chiller/heat exchanger which cools the fluoroscopy machine in the hospital's interventional radiology (ir) dept.The water chiller's capacitator failed causing a fire.Patient was not in room at time of fire.Equipment had been turned on in preparation for procedure, but fluoroscopy machine was not yet in use on patient.Staff walking by the room heard loud cracking/popping noises in the equipment cooling room.Staff then noted flames shooting out of the water chiller.Smoke caused fire alarm activation.Fire was contained and extinguished itself after equipment was turned off.Overheating error alarm had occurred one month prior; biomed serviced the chiller and added water to it.Biomed did not note any leak in the system; however, there were towels noted on the floor in the equipment room suggesting the machine may have been leaking fluid.Ir staff reported the machine had been "running hot" that week.After the fire, the chiller was drained, noting only 1l of fluid.Chiller normally contains 4l.Suggestive of possible leak.However, biomed opined that capacitator failure/defect caused the device to overheat, causing the fire.

• Brand Name: ARTIS ZEEGO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC; 40 liberty boulevard; malvern PA 19355
• MDR Report Key: 9734828
• MDR Text Key: 180218675
• Report Number: 9734828
• Device Sequence Number: 1
• Product Code: OWB
• 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: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2020
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1