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

Model Number	11007641
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported issue.A supplemental report will be submitted if additional information becomes available.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the sensis vibe hemo system.During an emergency patient procedure, a message about a software update appeared on the screen and could not be closed by the user.The patient had to be relocated to an alternative system to complete the procedure.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
The investigation was completed with the following results.The detailed log file analysis revealed that the system message ¿co2 module calibration¿ was displayed to the user.Following this event, the system underwent a hard power off for an unknown reason.After the system was powered up, a message regarding a sw update was displayed, which was deferred successfully.Directly after another message was displayed: "the system has lost communication with the hemobox.Check the ethernet connections between the control room and the hemobox.If problem persists, please contact service." then the system has been shut down.The onsite service intervention by a local siemens service engineer showed no deficiencies, despite a disconnected ¿rtc display¿ cable, which was not related to communicated effect.It was confirmed that the sw update could be postponed by selecting an install later.Unfortunately, no cause could be determined retrospectively.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.

• Brand Name: SENSIS VIBE HEMOSENSIS VIBE HEMO
• 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: 24161033
• Report Number: 3004977335-2026-00011
• Device Sequence Number: 21110274
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: (01)04056869010199
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K223812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: 11007641
• 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: 01/14/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 01/23/2026
• Supplement Report FDA Received Date: 03/23/2026
• 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