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

Model Number 6634633

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 02/26/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).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).

Event Description

It was reported to siemens that a malfunction occurred while operating the axiom sensis, hemo low system.During an emergency case there was no contact with the signal input board and no measurements were possible.The user reported that the patient passed away.At this time it is not known what type of procedure was being performed or the patients condition prior to examination.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.The investigation showed that the real time computer (rtc) had been running for over 124 days straight without any reboot and temporarily lost its communication to the signal input box (sib).The operator instruction clearly states that the system has to be rebooted at least every week, in order to prevent the error described.If the error has already occurred, no restart is required.An error dialog appears on the monitor and after error acknowledgement the system restores itself and the procedure can be terminated.Independent of this and for factors not due to failure of the system, the (b)(6) years old patient passed away.No corrective action on site was necessary as the system rebooted and recovered.The local service organization has instructed the customer that regular full-system-reboot is mandatory.The manufacturer is not considering further actions at this time.

• Brand Name: AXIOM SENSIS, HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 7337233
• MDR Text Key: 102314210
• Report Number: 3004977335-2018-19034
• 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: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2018
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death