MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848283

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

Exemption number e2017017.(b)(4).Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.

Event Description

It was reported to siemens that a malfunction occurred while operating the artis q zeego system.During an interventional procedure, the user reported receiving a "tube hot" error message.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.Based on an environmental issue, the temperature in the technical room was too high and therefore outside the specification.Each electrical device and medical system has a specified tolerance range in which it was tested and in which the functionality is guaranteed.Upon investigation, the customer service engineer reported that the temperature in the technical room was 38.6°c due to a failure of the customer's air conditioning system.The elevated temperature caused a rise in the system cabinet as well as an increase in the temperature of the coolant.If a coolant or temperature problem occurs during the procedure, a 30 minute countdown is displayed to the user on the monitor.This safety measure allows the user to complete a procedure in a controlled manner.According to the user manual the system can be used in a temperature range from 15 to 30°c.After the customer repaired the air conditioning system the medical system worked as specified.This kind of failure is considered a user error as the customer is responsible for the air conditioning unit.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: ARTIS Q ZEEGO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8300750
• MDR Text Key: 134851707
• Report Number: 3004977335-2019-65588
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K141574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

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: Health Professional
• Device Model Number: 10848283
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/18/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2019
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 03/21/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1