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

Model Number	11007641
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
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
It was reported to siemens healthineers that a malfunction occurred while using the sensis vibe hemo.During an emergency procedure, the user stated that there was no ecg monitoring available during the procedure.The procedure was continued and finished using an alternate system.We have no indication of any adverse effects on 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 performed by considering complaint description, customer service reports, & system history.During an emergency procedure, the ecg (electrocardiogram) could not be displayed.The procedure was then performed using an alternative system.No health consequences were communicated.For troubleshooting the system was restarted and the ecg trunk cable was replaced, but this didn¿t solve the issue.Customer service engineer went onsite to check the system.The system was fully operational on arrival and the issue could not be reproduced.During investigation the exact root cause of the outage of the ecg signals could not be identified.According to the provided information there is no indication of a system deficiency.However, the error pattern indicates that the outage of the ecg signals may be caused by the ecg signals drifting outside of the dynamic range of the hisib (hemo integrated signal input box), which is responsible for the vital sign signal acquisition.The cause of the ecg signals drifting out of range may be due to a number of contributing factors related to ecg handling.Most common cause is a bad contact between ecg electrodes and patient skin.The occurrence rate of the 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: jenna keefe ; 40 liberty blvd.; malvern, PA 19355 ; 4843234206
• MDR Report Key: 21686066
• Report Number: 3004977335-2025-00045
• Device Sequence Number: 8773989
• Product Code: DQK
• UDI-Device Identifier: 04056869010199
• UDI-Public: (01)04056869010199
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

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: 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: 02/27/2025
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 03/25/2025
• Supplement Report FDA Received Date: 04/08/2025
• 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