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

Model Number	11007642
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens healthineers is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A follow-up report will be filed upon completion of the investigation.
Event or Problem Description
Siemens became aware of a malfunction that occurred while operating the sensis vibe combo.During an interventional procedure, the user reported that the system froze during the procedure and an injury was communicated.The procedure was continued using the same system.We are unaware of any impact to the state of health of the patient involved.Siemens healthineers has requested additional information in order to investigate the reported event.
Additional Manufacturer Narrative
The investigation was completed by our experts.In the initial report a patient injury was communicated.However, after further clarification with the customer it was determined that there was no patient harm or any health consequences.The blue screen error message of the operating system indicates a system crash, which can happen due to various reasons.The error appears when the unit¿s operating system can no longer function properly.When the blue screen comes up, the operating system shuts down automatically to recover from the critical error and initiates a reboot.Analysis of the log files confirmed the issue; however, the root cause of the crash could not be identified retrospectively.Therefore, a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: SENSIS VIBE COMBO
• 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: 22052730
• Report Number: 3004977335-2025-00065
• Device Sequence Number: 5355401
• Product Code: DQK
• UDI-Device Identifier: 04056869010205
• UDI-Public: (01)04056869010205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2025

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: 11007642
• 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: 05/05/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/23/2025
• 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