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

Model Number 6634633

Device Problem Use of Device Problem (1670)

Patient Problem Death (1802)

Event Date 12/12/2019

Event Type  Death  

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 and subsequent adverse event occurred while operating the axiom sensis hemo low system.The user reported that the dialog monitor computer (dmc) froze during a patient angioplasty for approximately 7 to 8 minutes.The system restarted itself and the examination was continued.It was later reported that the patient passed away.The cause of the patient death is unknown currently.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Additional information has been provided to siemens on december 20, 2019 that the patient's death was not caused by the siemens system.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.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The incident described in the complaint is was investigated as two claims: claim1: sensis dmc system frozen: the customer claimed the system froze for 7-8 minutes during exam, however, log files show that the system froze for 3,5 and 4 minutes during the procedure.There were no waveforms on the dialog monitor computer (dmc) and real time computer (rtc) during the issue.The system was able to recover from the error by itself and the user continued the procedure on the sensis.Claim2: patient death during the procedure: after the issue occurred the user continued the study for around 50 minutes and then performed closing of the study.There were user actions on the sensis system once the system recovered from error and in the logs we can see that there were hard rate alarm events being created with valid hard rate values which indicates that the patient was alive after the initial dmc freeze.Therefore, vital sign monitoring was available prior to and at the time of the patient death and the user would have been aware of a decline in the patient's health.As per discussions between the service technician and the physician who performed the procedure, the sensis issue did not cause or contribute to the patient death.The main permanent storage device on the sensis dmc-pc is a solid state drive (ssd), and the application runs off of this drive.If this ssd becomes non-functional, the sensis user interface becomes frozen.The user must wait a few minutes for the system to recover and continue working normally.As the ssd was not available immediately, the service technician replaced the full hp system on site to resolve the issue.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: AXIOM SENSIS HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 9494777
• MDR Text Key: 171976761
• Report Number: 3004977335-2019-11693
• 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,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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
• Date Manufacturer Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death