MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ICONOS R200; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 5902775

Device Problem Unintended Movement (3026)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

The user stated that the system started tilting without given command from 90 degrees to 0 degrees during a patient exam.The patient was sitting in a chair.The user stopped system movement by turning off the system.There was no injury reported due to the event.Patient information was not provided to siemens.The user can stop system movement at any time by pressing the emergency stop button.It is assumed that in worst case scenario the issue might cause minor to serious injury in case of recurrence.Additional information has been requested.The reported event occurred in spain.

Manufacturer Narrative

Manufacturers preliminary analysis: the cause for the issue has not been determined yet.Further information was requested.Investigation is ongoing.Initial corrective actions/preventive actions implemented by the manufacturer: investigation is ongoing.Corrective or preventive action is not being considered as of the date of this report.A supplemental report will be submitted if addition information becomes available.Internal id# (b)(4).

Manufacturer Narrative

G4: 510(k) number was incorrect and reported in error.The correct 510(k) is k992660.

Manufacturer Narrative

H10 manufacturer narrative: the reported event was investigated in detail.At the affected system, an unintended tilt movement was reported to siemens on (b)(6) 2021.For this issue, the replaced joysticks were examined, but since the error occurred only sporadically, no fault was found.This issue was not deemed reportable to the fda.It was stated that the system made another tilt movement without command on (b)(6) 2022.The movement was stopped by turning the system off at the generator console.The customer was instructed to stop using the system until the repair was completed.Regardless, the customer continued to use the system and another unintended tilt movement occurred on (b)(6 )2022.The user was again instructed to stop using the system.The analysis of the provided error log files did not reveal any unintended movements.All movements were classified as intentional by the scu software.This means that they could only have been triggered by the table side or the remote control.For further investigation, the following parts have been replaced and returned: assembly group buc (basic unit controller, material number 5901793) remote control desk (material number 7030708) table side control (material number 7030773) the spare part consumption of the concerned parts shows values that are below the defined threshold.The parts were investigated by the supplier of the system.The buc controller was very dusty.Residue could be seen all over the controller.Since the affected iconos r200 was installed in 2001 this may be a reason for this dust accumulation.If the air humidity is high, the dust becomes moist.This can lead to an unintentional connection of electrical components.However, this cannot be reproduced afterwards.For this system type, the buc is no longer available as a new part, but only as a repair part.Nevertheless, no other abnormalities were detected visually.The remote-control desk was checked but did not show any visual abnormalities.On the table side control also no visual abnormalities on the front side were found.However, a dark solder joint was visible on the back side.The functionality of the affected pin was checked.Since this is one of several grounding pins, it can be excluded as cause of the triggered movement.Finally, the visual inspection of the table side control and the remote-control desk revealed no evidence of liquid ingress.To check the correct function, the replaced parts were installed in the test station of the supplier of the system.The buttons on the table side and the joysticks at the remote-control desk functioned as specified.All axles were moved several times.This confirmed the functionality of all control elements.The "virtual unit" was moved to +90° and observed for two hours.The axles were then driven again to observe the positions of all axles overnight.In all these tests, no unintended movement of the tilting axles was observed.As an additional functional check, the system was started with the joystick for tilting actuated.The buc generated an error message, opened the safety circuit, and blocked the axis for tilting.This confirms that the buc is operating as specified.No unintended movement could be generated.During all tests, the described behavior could not be reproduced.The investigation of the replaced parts did not reveal any malfunction.According to the received information, the issue was solved at customer site with replacement of the remote-control desk, table side control and assembly group buc.In addition, the software was updated to ve00c, as recommended in xp014/12/r.However, this system update does not affect potential unintended tilt movements, but only improves the system control to prevent sporadic system stops.In case of unintended movements, the operator can press the emergency stop buttons at any time.With these, all drives of the system are switched off and all movements are stopped immediately.On (b)(6 ) 2022 it was confirmed that the user was instructed to report any further problems.A monitoring phase was agreed during which the system should be used with special care and any unintended movements or tilting should be reported immediately.On (b)(6) 2022 the service engineer confirmed that no further unintended movements had occurred since the potentially affected parts were replaced.The complaint has been closed without further measures.H11 corrected data: b1, b2: adverse event and other serious or important medical events were checked in error in the initial report submitted on july 12, 2022.Product problem should have been checked.B4: date of this report in initial report should have been july 12, 2022.D8: device was serviced by siemens and should have been checked "no".H8: usage of device was incorrectly checked as "reuse" in initial report.This field should have been blank.

• Brand Name: AXIOM ICONOS R200
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim; forchheim, 91391 ; GM 91391
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstr. 1 or rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 14985178
• MDR Text Key: 295891689
• Report Number: 3004977335-2022-34774
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K992660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5902775
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/12/2022
• Supplement Dates Manufacturer Received: 06/29/2022; 11/25/2022
• Supplement Dates FDA Received: 07/12/2022; 12/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other