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

Model Number	11007641
Medical Device Problem Codes	Communication or Transmission Problem (2896); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Siemens became aware of a malfunction while operating the sensis vibe hemo system.During an emergency procedure, the system failed to display vital signs and curves as communication with hemo integrated signal input box (hisib) was lost.The patient had to be moved and the procedure was continued on an alternate unit.We have no indications of any adverse effects on the health status of the involved patient.
Additional Manufacturer Narrative
Siemens is conducting a thorough investigation of the reported event.A supplement report will be filed if additional information becomes available.Section h6 code 4755- hemo integrated signal input box (hisib).
Additional Manufacturer Narrative
H3, h6: siemens healthineers has completed the investigation of the reported issue.Siemens healthineers was made aware that during an emergency procedure, the communication with hemobox (hemo integrated signal input box) was lost.As a result of this no vital signs and curves were displayed on the monitors.The procedure was continued by relocating the patient to an alternative system.No patient health consequences were reported to this event.Detailed investigation confirmed that the here reported issue occurred during patient examination and caused vital sign acquisition to stop.The following error message was displayed to the user: "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." the issue is due to the hemobox is not responding to the ping from the dmc (dialog monitor computer).The investigation revealed that the connection between hemobox and dmc could not be established again.The hemobox was replaced as part of the service activity.The occurrence rate of the aforementioned 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 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: rebecca tudor ; 40 liberty blvd., mc 65-1a; malvern, PA 19335 ; 4843234198
• MDR Report Key: 18427525
• Report Number: 3004977335-2024-00168
• Device Sequence Number: 15457417
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• 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): 02/22/2024

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: 12/27/2023
• Supplement Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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