MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT CIOS SPIN; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number	10308194
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported to siemens that a malfunction occurred while operating the cios spin system.In preparation for the 3d scan, the c-arm automatically moved to the end position to start the test run.This was interpreted as an unintended system movement.There is no report of impact to the state of health of any patient or user involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
The investigation revealed that there was no system failure and the system was operating as specified.It was reported that an unintended motorized movement occurred on a cios spin system.The incident occurred on a customer test system that had a new third-party navigation marker frame installed for testing purposes.The test was initiated by the company (nuvasive).The attachment of the said test object meant additional weight and incorrect load distribution at the system.This resulted in a different mechanical load and the mentioned movement behavior described in the complaint.The log files of the system were analyzed and there was no evidence of unintended motorized movement.The reported incident was also reproduced by siemens test center and no motorized movement could be observed.Instead, there was a mechanical movement caused by additional weight attached by a third party for testing purposes.In addition, the application specialist confirmed that the sound of mechanical movement was misidentified as the sound of motorized movement.The mentioned third-party component has been removed.No similar incidents have been reported.

• Brand Name: CIOS SPIN
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 12197045
• Report Number: 3004977335-2021-88581
• Device Sequence Number: 1323552
• Product Code: OWB
• UDI-Device Identifier: 04056869153506
• UDI-Public: 04056869153506
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K210054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2021

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
• Operator of Device: Health Professional
• Device Model Number: 10308194
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2021
• Supplement Date Received by Manufacturer: 08/30/2021
• Initial Report FDA Received Date: 07/20/2021
• Supplement Report FDA Received Date: 08/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1