MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH-AT SENSIS VIBE HEMO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number	11007641
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
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 operating the sensis vibe hemo system.The user reported that after booting the system, it displayed a blue screen indicating that windows needed to be repaired.This caused a long term delay which occurred before an emergency procedure.There is no report of impact to the state of health of any patient or user involved.
Additional Manufacturer Narrative
H10: manufacturer narrative: h3, h6: siemens healthineers completed the investigation of the reported event.The investigation was performed based on expert discussions, consideration of the complaint description, customer service reports, system history, system log files and event simulation.According to the provided information, the system got stuck in start-up mode when booting up after a reboot or when turned on.Furthermore, the issue happened before an emergency procedure which caused the exam to be delayed.No health consequence was communicated.For the described scenario, the root cause investigation is not possible by log file analysis, as the system is not logging during system boot up.It can just be confirmed when the system was shutdown.The logs show that the issue did not happen on the reported day of the event, but the system was shut down the day after and turned on again another day later.To detect any hardware (hw) problems, a hw diagnostic test via bios was performed on site to determine any problems with the drives or memory.All tests were performed without any malfunctions.Therefore, attempts were made to reproduce the problem in the laboratory through various test cases, such as multiple (300 times) automatic system restarts or multiple hard shutdowns instead of the shutdown procedure described in the operating manual.The problem could not be reproduced in the laboratory.Even on site, the error no longer occurred.The occurrence rate of that error pattern was checked.A possible error accumulation or even a systematic error, which leads to a corrective action of the installed base, could not be determined by the investigation.

• Brand Name: SENSIS VIBE HEMO
• Common Device Name: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1- or-; rittigfeld 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16730719
• Report Number: 3004977335-2023-69388
• Device Sequence Number: 6663539
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/26/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown