MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE CEILING; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094137

Device Problems Use of Device Problem (1670); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2020

Event Type  malfunction  

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.Internal id # (b)(4).

Event Description

It was reported to siemens that a 3d run aborted on the artis pheno unit.The issue happened twice with two different patients.It is unclear whether any injuries are attributed to this incident.The reported issue occurred in (b)(6).

Manufacturer Narrative

Siemens completed the investigation of the reported event.Unfortunately, the investigation did not reveal a clear root cause.Although the returned part has been examined and the logfile has been reviewed the root cause of the error mentioned in the complaint could not be definitively determined.According to the system specialists the most proper reason is a sporadic defect of the multi display manager (mdm) which is responsible to control the large display.This thesis is supported by the fact that the system worked well after exchanging the mdm.Finally, this investigation could not show any systematic issue or even an error burst; so, no approaches for improvements could be identified.No further measures are necessary.

Manufacturer Narrative

In initial report date (b)(6) 2020 was reported.Corrected data is (b)(6)2020.

• Brand Name: ARTIS ZEE CEILING
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10191933
• MDR Text Key: 198150665
• Report Number: 3004977335-2020-32957
• Device Sequence Number: 1
• Product Code: OWB
• UDI-Device Identifier: 04056869010052
• UDI-Public: 04056869010052
• Combination Product (y/n): N
• PMA/PMN Number: K181407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 06/24/2020

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: 10094137
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/06/2020
• Initial Date FDA Received: 06/24/2020
• Supplement Dates Manufacturer Received: 06/06/2020; 07/31/2020
• Supplement Dates FDA Received: 06/24/2020; 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other