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

Model Number 10094135

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 08/23/2019

Event Type  Death  

Manufacturer Narrative

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 zee floor system.During an emergency procedure, no x-ray was possible resulting in a delay in procedure.The customer reported that the patient passed away, however, the system delay did not lead to the death of the patient.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 temporary hardware issue.The cause of the patient death was due to other health complications and not in relation to the siemens product.During booting; no connection between the realtime computer (rtc) and the image acquisition (ias) was possible.This led to the absence of x-ray in one plane of a biplane system.The other plane was not affected.A service technician checked the system on site; however, the issue could not be reproduced.Confirming the customer claim in the logs, the cse reseated boards in both the rtc and ias preventively.After passing all tests, the system was returned to the customer fully operational.The detailed investigation of the logs, prior to and after the event, identified no systemic failure and therefore a onetime occurrence is identified.Additionally, the fact that the system worked well after reseating boards and plugs indicates a temporary contact problem without any error accumulation.The affected parts have been reseated by the local service organization and the error did not reoccur.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, 91301 ; GM 91301
• MDR Report Key: 8945051
• MDR Text Key: 155970185
• Report Number: 3004977335-2019-95353
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death