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

Model Number 06634633

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/30/2017

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.This event occurred in (b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the axiom sensis hemo low system.During an emergency procedure, the sensis system could not be started.No curves where shown on the live monitor and the patient could not be registered.The patient was safely removed from the system and transferred to an alternate system where the procedure was completed.We are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The system self-test indicated error messages, leading to communication problems between signal input box (sib) and real time computer (rtc).This problem could be caused from cable - or contact problems or interruption of power supply.Nevertheless, there is no evidence of a power failure during the time in question.Finally there is no clear evidence what finally caused the error in detail.Removal of the syngo database and check of the conductivity between sib and rtc via service.The problem did not recur.The problem does not present a total loss of the complete system.After the corrective action the problem was not communicated since.The manufacturer is therefore not considering further actions resulting from this event.

• Brand Name: AXIOM SENSIS HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 6849082
• MDR Text Key: 85159445
• Report Number: 3004977335-2017-04556
• 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
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 06634633
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/30/2017
• Initial Date Manufacturer Received: 08/30/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1