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

Model Number 11007642

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Application Program Problem (2880)

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

Event Date 03/27/2024

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.A supplement report will be filed upon completion of the investigation.

Event Description

Siemens became aware of a malfunction that occurred while operation the sensis vibe combo unit.During an interventional procedure, the user noticed that the heart rate displayed by the system was higher than the rate displayed on the anesthesia monitor.We have no indications of any adverse effects on the health status of the involved patient.

Manufacturer Narrative

Siemens has completed an investigation of the event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The investigation was performed considering complaint description, cs reports, system history, system log files, and complaint parts.During an interventional procedure, the heart rate displayed by the sensis system was erratic and higher than the heart rate displayed by a third part anesthesia monitor.This issue occurred during atrial fibrillation of the patient.The procedure was continued on the affected sensis system while simultaneously monitoring the patient with the anesthesia monitor.We are unaware of any impact to the state of health of the patient involved.During the investigation it was verified that the heart rate was displayed correctly by the sensis system while performing a test study with a simulator.System settings were checked, and no issues have been identified.As issues with the heart rate can be caused by a failure in the signal chain, the trunk cable for the electrocardiogram (ecg) measurement was replaced as a preventive measure.The investigation of the replaced ecg trunk cable showed no errors.The heart rate is calculated by the sensis system based on ecg signals.Atrial fibrillation is a type of arrhythmia that displays as an abnormal ecg signal.Due to the abnormal ecg signal the heart rate calculation is affected.Depending on the algorithm used by the monitoring system to calculate the heart rate, different systems can display different heart rates during atrial fibrillation.In general, atrial fibrillation is a medical condition in which an abnormal heart rhythm (arrhythmia) occurs, and no regular heart rate is calculated.The occurrence rate of the error pattern was checked.A possible error accumulation or even a systematic error, which would lead 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: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 4843231631
• MDR Report Key: 19168450
• MDR Text Key: 341359777
• Report Number: 3004977335-2024-00043
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 04056869010205
• UDI-Public: 04056869010205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/14/2024

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
• Device Operator: Health Professional
• Device Model Number: 11007642
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/23/2024
• Supplement Dates Manufacturer Received: 08/14/2024
• Supplement Dates FDA Received: 08/14/2024
• 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