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

Model Number 11007641

Device Problem Use of Device Problem (1670)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.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 a malfunction occurred while operating the sensis vibe hemo system.During a procedure, the user reported that the system rebooted by itself.We are unaware of any impact to the state of health of the patient involved.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 root cause was determined to be a software error.This case was reported because the complaint alleged a system crash or a breakdown of the entire system, however, an in-depth investigation could not confirm this.Rather, the live monitor, which displays the vital parameters of the patient, never failed.According to the log file and the simulation in the laboratory, only the automatic calculation of the output rate of the heart (fick cardiac output calculation) could not be performed.If this calculation type is repeated, a software error occurs during the automatic data transfer, which is triggered by a check mark to be set by the user, and the cardiac output calculation value is not calculated.The error is obvious to the user because the system does not supply any value at all.However, the desired output rate can be determined by deselecting the above check mark or by manually entering the calculation parameters.It is also important to understand that this does not take place on the live monitor, but on a separate second monitor.The "reboot" mentioned in the complaint referred exclusively to this second monitor to its upstream personal computer (pc).The live monitor/pc, which displays the vital parameters, was fully functional and worked properly.No parts had to be replaced on site and the above checkbox has already been deactivated.The error mentioned in the complaint did not reoccur.Additionally, a new software version is planned to be released with ax054/19/p in q4/2019 to further improve the system performance.

• Brand Name: SENSIS VIBE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, 91301 ; GM 91301
• MDR Report Key: 9086813
• MDR Text Key: 190829023
• Report Number: 3004977335-2019-91694
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• 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
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1