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

Model Number	10308194
Medical Device Problem Codes	Use of Device Problem (1670); Radiation Output Failure (4027)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2020
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 using the cios spin system.During an emergency procedure, the user reported that no x-ray was possible.The procedure was continued and finished on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
Additional Manufacturer Narrative
The investigation showed that the reported system behavior is a sporadic timing issue of the software.This leads to a medium-term unavailability of x-rays and, thus, to the absence of the imaging function.The described behavior occurs during start-up, after patient registration, however, it can be corrected by a system reboot.The device will be fully functional following the reboot.However, a change request has been triggered and this performance issue may be considered in future software versions.

• Brand Name: CIOS SPIN
• Common Device Name: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10190346
• Report Number: 3004977335-2020-33179
• Device Sequence Number: 3408408
• Product Code: OWB
• UDI-Device Identifier: 04056869153506
• UDI-Public: 04056869153506
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 10308194
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/06/2020
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1