MAUDE Adverse Event Report: SIEMENS HEALTHCARE ARTIS ZEE BIPLANE; ANGIOGRAPHIC X-RAY SYSTEM

Model Number 10094141

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

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

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.A supplement report will be filed upon completion of the investigation.This report was submitted january 3, 2017.

Event Description

Siemens became aware of an error that occurred on the artis zee biplane unit during a patient procedure.The patient was taken to the cath lab for embolization.As a physician was about to begin the procedure after prepping and intubating the patient, the system displayed a message "hot tube".The procedure had to be interrupted and the patient was transported to another cath lab room.It was determined the cooling mechanism for the c-arm ran out of water to cool down the tube causing it to overheat.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.During the investigation, it was determined that the cooling-unit of the x-ray tube is not able to provide proper cooling to the x-ray tube.This occurred only on plane a of a biplane system and plane b was not affected and continued working without any limitation.To prevent further damage of the x-ray tube of plane a, the operation was stopped and the operator decided to continue on another system.Following the exchange of the x-ray tube cooling unit, the system works as specified and the issue did not recur.The manufacturer is not considering further actions resulting from this event.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE; siemensstrasse 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6218320
• MDR Text Key: 64025906
• Report Number: 2240869-2017-63568
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/07/2016

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
• Device Model Number: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other