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

Model Number 11007641

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/03/2017

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.(b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the axiom sensis vibe system.During a procedure the patients ecg signals were lost and tracing could not be completed.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 root cause was determined to be the loss of ecg signal due to poor quality electrodes.If the user is not following proper skin-preparation and ecg acquisition techniques, the signal may be out of range.Poor quality electrodes (not recommended by siemens) were determined to be the largest contributing factor at this site.These particular electrodes responded to the lead-off and right-leg-drive current by polarizing over the time.A siemens service engineer installed a new high integrated signal box, which includes a reduction in right leg drive current.Furthermore, the customer is testing a supply of ambublue electrodes which show a much higher performance.Additionally, a software- and hardware field corrective action is planned to be released in q2/2018, which will provide a dynamic gain change in the hisib.

• Brand Name: AXIOM SENSIS VIBE HEMO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 6934760
• MDR Text Key: 90044183
• Report Number: 3004977335-2017-97416
• 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: 09/19/2017

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: 11007641
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 03/02/2018
• Supplement Dates FDA Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1