MAUDE Adverse Event Report: SIEMENS HEALTHINEERS AG SENSIS; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	10764561
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	Cyanosis (1798)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the sensis system.During a patient procedure, the device displayed an incorrect spo2 value.The device showed the sp02 reading at 100% while the patient skin turned bluish.Detailed investigation into whether, and to what extent, the system contributed to this condition is currently ongoing.The procedure was continued on an alternate system.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported issue.A supplemental report will be submitted if additional information becomes available.
Additional Manufacturer Narrative
The detailed investigation of the reported event and the provided log files identified no deficiencies or malfunctions of the siemens sensis system.The analysis, however, did indicate that the spo2 readings were unstable; with the sensis system intermittently displaying either the spo2 value (fluctuating rapidly in the range of 85-98) or no value at all.This behavior is consistent with one or more of the following conditions: - loose sensor connection.- intermittent or missing communication with the spo2 sensor.- defective spo2 sensor hardware.The sensis system does not modify, filter, or post-process spo2 values received from the sensor.All spo2 data displayed on the real-time screen reflects the values provided directly by the spo2 sensor.Furthermore, the sensis system stability was verified, ruling out any potential for system freezes or software errors.The spo2 sensor was identified as the likely root cause.Furthermore, this conclusion is supported by the absence of further incidents following the replacement of the affected sensor.The defective sensor was disposed of by the user and, therefore, was not available for further investigation.As the spo2 sensor is an oem component, the manufacturer nonin was informed.The sensis system operated as intended and within specification.

• Brand Name: SENSIS
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHINEERS AG; siemensstrasse 1 -or-; rittigfeld 1; forchheim 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd.; malvern, PA 19355 ; 4843234197
• MDR Report Key: 24616158
• Report Number: 3004977335-2026-00036
• Device Sequence Number: 18600303
• Product Code: DQK
• UDI-Device Identifier: 04056869010137
• UDI-Public: (01)04056869010137
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2026

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown