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

Model Number 10094141

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

(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.(b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.During a clinical procedure radiation was generated without pressing the system footswitch.There is no report of impact to the state of health of any patient or user involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.No systematic issue could be identified.The investigation of the log files did not indicate an un-commanded release of x-ray.Each request to release x-ray was enabled by the table footswitch connected to the system.The time stamps in the log files do not show normal user behavior as it indicates that during the time of acquisition the footswitch was pressed and released several times.The user confirmed that the footswitch was defective and the hospital engineer attempted to fix the problem by applying unauthorized modifications to the footswitch.These modifications led to poor waterproofness of the footswitch.The user tested the footswitch by pouring water on it.The system reacted by generating radiation.A siemens service engineer went onsite and replaced the footswitch.The replaced defective footswitch was returned for investigation and it was confirmed that the unauthorized modifications by the hospital engineer lead to the reported system behavior.After the footswitch was replaced the issue was resolved.In the instructions for use it is clearly stated that the user may not repair or modify the system or its components.No further corrective action is planned at this time.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 6861679
• MDR Text Key: 86091466
• Report Number: 3004977335-2017-93099
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

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 the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2017
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 02/16/2018
• Supplement Dates FDA Received: 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1