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

Model Number 11007641

Device Problems Communication or Transmission Problem (2896); No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2023

Event Type  malfunction  

Event 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.

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).

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
• Type of Device: 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
• MDR Text Key: 331871648
• Report Number: 3004977335-2024-00168
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: 04056869010199
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11007641
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1