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

Model Number 6634633

Device Problem Computer Operating System Problem (2898)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/27/2021

Event Type  Death  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.At this time, there is no causality between the system error and the patients death.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 Description

It was reported to siemens that an adverse event occurred while operating the sensis vibe hemo low system.During an emergency procedure, the user reported that the sensis dialog monitor computer (dmc) restarted itself.The patient had to be reanimated and a mobile electrocardiogram (ecg) system was used.The vital signs of the patient were continuously visualized by the user.It was reported that the patient passed away.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The system functioned properly during the procedure and there was no connection between the patient's death and the sensis system.The sensis system is equipped with several sub-components.The dmc (dialog monitor computer) restarted due to a temporary error.The rtc (real time controller) was not affected by this and the vital signs (live monitor with measurement curves) were continuously visualized to the user.The incident occurred at the end of an emergency cardiac procedure.It was reported that the patient passed away.The available log files indicate that an emergency procedure was performed and the procedure was completed before said reboot of the dialog monitor/pc occurred.This information was also confirmed by the customer, who stated that the system functioned properly during the procedure and that there was no connection between the patient's death and the sensis system.According to the log files, the restart of the dmc did not occur until after the patient's death.Therefore, the system was able to display vital signs via the live monitor at all times.Restarting the dialog monitor is the mitigation for such a temporary problem and restores system functionality, as it did in the given case.At the time of the event, the sensis system was functioning as intended and the problem occurred only after an attempt was made to end the exam computer-wise and close the patient data-wise.The primary cause of the restart was an overfilled local database.The database is capable of storing approximately 100 patients locally.However, it was reported that many more patients were stored here, which were later cleaned up.A corresponding note is well described in the user manual.After cleaning up the database, the system worked as specified and no further problems have been reported.The occurrence rate of the problem was checked.Any accumulation of errors, or even a systematic error that would lead to corrective action of the installed base, could not be detected by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: SENSIS VIBE HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; malvern, PA 19355 ; 6104486461
• MDR Report Key: 12560634
• MDR Text Key: 274205516
• Report Number: 3004977335-2021-98673
• Device Sequence Number: 1
• Product Code: DQK
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6634633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death