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

Model Number 6634633

Device Problem Insufficient Information (3190)

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

Event Date 09/19/2017

Event Type  malfunction  

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.

Event Description

It was reported that the axiom sensis hemo low system froze seven times during an acute procedure.There are no injuries attributed to this event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The investigation showed the issue was cause by a software behavior called "neptune disconnect".Neptune disconnect is an incorrect calculation of number of lost samples which triggers the display of (normal blood pressure) nbp-related error messages.In such cases, the operator closes and resumes the study to clear the nbp fault.This process is described within the operator instruction.If the nbp functionality is lost and the user decides to reboot, the user must follow the operator instructions for proper system re-boot: axa5-200.620.07.Xx chapter: system reboot, page 145.This software behavior has been eliminated from software version vc12m on as of 1/29/2018 via update ax029/17/p.The manufacturer is not considering further actions resulting from this event as a measure is available.

• Brand Name: AXIOM SENSIS HEMO LOW
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim 91301 ; GM 91301
• MDR Report Key: 6952355
• MDR Text Key: 90472978
• Report Number: 3004977335-2017-96875
• 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
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6634633
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other