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

Model Number 10094135

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 12/27/2018

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.(b)(4).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee floor system.During an interventional procedure, the user reported that no communication message was displayed and no x-ray or system movements were possible.The patient was safely removed from the system and transferred to an alternate system where the procedure was completed.We are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a defective component.The log file analysis shows that the image system lost the communication to the real time controller (rtc), which could not be reestablished even with a reboot.As a result, the release of x-ray as well as system movement became unavailable.Upon investigation, the customer service engineer found the rtc completely off.After its replacement the system recovered.The detailed investigation of the returned rtc showed a defective power supply.A systematic error was not detected.Due to the defective power supply the real time controller (rtc) has been exchanged by the local service organization.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: ARTIS ZEE FLOOR
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8239345
• MDR Text Key: 133536583
• Report Number: 3004977335-2019-62950
• 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,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

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: 10094135
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/27/2018
• Initial Date Manufacturer Received: 12/27/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1