MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM SENSIS; PROGRAMMABLE DIAGNOSTIC COMPUTER

Model Number	10764561
Medical Device Problem Codes	Radiation Output Problem (4026); Radiation Output Failure (4027)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of this event.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(4).
Event or Problem Description
It was reported to siemens that a malfunction occurred while operating the axiom sensis system.During a patient procedure, the user reported a signal acquisition error.The patient was transferred to an alternate device to complete the procedure.There are no injuries attributed to this event.
Additional Manufacturer Narrative
The investigation was completed by our technical experts.The log file analysis showed that shortly after starting the exam the sinon application crashed and the signal acquisition error messages were presented to the user.The sinon application is responsible for communication between the dialog monitor computer (dmc) and integrated signal input box (isib).If this sinon application is not running, no communication with the system is possible.No software errors can be seen in the logs before the application crashed.This indicates a power issue of the isib.A full system reboot should power down the dmc and the isib bringing up all other components to normal state.However, the isib component remained down after the full system reboot, this further indicates a power issue of the isib.The root cause for the isib power issue was loose cabling.The customer service engineer inspected the unit and found that cables had been pulled from the isib.The fiber optic cable and the 18v power cable were put back into the isib.Additionally, the cables were re-routed to prevent pulling.

• Brand Name: AXIOM SENSIS
• Common Device Name: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 10905684
• Report Number: 3004977335-2020-52003
• Device Sequence Number: 14223991
• Product Code: DQK
• UDI-Device Identifier: 04056869010137
• UDI-Public: 04056869010137
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K150493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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: 10764561
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 01/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other