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

Model Number 10849000

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.

Event Description

Siemens became aware of a malfunction on the artis pheno system.It was reported that during an emergency patient procedure, no movements were available on the x-ray stand.The user tried to re-start the unit with no success.The patient was moved to an alternate unit to complete the procedure.We have no indications of any adverse effects on the health status of the involved patient.

Manufacturer Narrative

H10: manufacturer narrative: h3, h6: the investigation was performed based on expert discussions considering complaint description, customer service reports, system history, and system log files.According to provided information, no stand movement was possible during an emergency procedure.The procedure was then continued and finished using an alternative system.No health consequences were reported to this event.The investigation of the log files revealed that the failure was already present with system startup.No connection could be established between the robot and ccom (central computing).As a result, system movement functionality was blocked.System restarts performed by the customer could not fix the problem.As part of reactive service activity, individual components (ccom, iob - input output box and robot) were restarted.The subsequent system check did not reveal any system problem.Unfortunately, both the on-site service intervention and the detailed investigation of the log files did not provide a clear picture of how this error occurred.The error mentioned in the complaint has not again been reported since then.The occurrence rate of the aforementioned error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.H11: corrected data: g2: report source health professional should have been checked on the initial report submitted to the fda on july 17, 2023.H11: corrected data: g2: report source health professional should have been checked on the initial report submitted to the fda on july 17, 2023.

• Brand Name: ARTIS PHENO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1 or; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; or rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 17332396
• MDR Text Key: 319600020
• Report Number: 3004977335-2023-00058
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K201156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10849000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1