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

Model Number 06634633

Device Problem Use of Device Problem (1670)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 11/07/2016

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.(b)(6).**resubmission of initial report as per fda on 7/28/20**.

Event Description

It was reported to siemens that an unstable patient with cardiogenic shock, acute heart attact and failure of a pace-maker was examined on the axiom sensis system.During the examination, some ecg signals were not avaialble.The customer attempted to restart the system several times without success.The patient was safely transported to an alternate system to continue the examination.It was reported that the patient expired during examination on the alternate system.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Investigation showed that a hardware error occurred on the real time controller (rtc) leading to two faulty boot-ups of the rtc pc.The root cause for this error was determined to be excessive dust deposits in the pc.The analysis of the log files of the vital parameters showed that the ecg signal showed a periodic short gap, approximately every 5 seconds.This error was present the day before the actual event.It can be assumed that the user had been aware of the ecg display problem displayed.The described complete failure of the display was based on contact problems of the video card with the socket on the motherboard due to excessive dust deposits.After cleaning, the video card showed no further failures.A check of the maintenance instructions showed that advice to vacuum the interior of the pc is not detailed.Correction for this failure has been initiated via update ax005/17/s and was reported to the fda under 21 cfr 806; report 2240869-04/13/17-0013-c.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Investigation showed that a hardware error occurred on the real time controller (rtc) leading to two faulty boot-ups of the rtc pc.The root cause for this error was determined to be excessive dust deposits in the pc.The analysis of the log files of the vital parameters showed that the ecg signal showed a periodic short gap, approximately every 5 seconds.This error was present the day before the actual event.It can be assumed that the user had been aware of the ecg display problem displayed.The described complete failure of the display was based on contact problems of the video card with the socket on the motherboard due to excessive dust deposits.After cleaning, the video card showed no further failures.A check of the maintenance instructions showed that advice to vacuum the interior of the pc is not detailed.Correction for this failure has been initiated via update ax005/17/s and was reported to the fda under 21 cfr 806; report 2240869-04/13/17-0013-c.

• Brand Name: AXIOM SENSIS
• 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; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, pa ; 4486461
• MDR Report Key: 6518365
• MDR Text Key: 202508732
• Report Number: 2240869-2016-06375
• Device Sequence Number: 1
• Product Code: DQK
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 06634633
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/21/2016
• Initial Date FDA Received: 04/25/2017
• 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