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

Model Number 6634633

Device Problem Use of Device Problem (1670)

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

Event Date 11/13/2019

Event Type  malfunction  

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.

Event Description

It was reported to siemens that a malfunction occurred while operating the axiom sensis hemo low system.During an interventional procedure, the user reported that the system froze.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause could not be determined.The investigation was performed considering complaint description, cs reports and system history.Based on the issue description, the involved customer service employee (cse) replaced the dialog monitor computer (dmc) orion pc.After its replacement the system works as specified.An extensive investigation could not be performed because the dmc orion pc was not returned as well as no log files were available.The cause of the complaint could not be determined retrospectively.After hardware replacement there were no further issues as described in the complaint description and the system works as intended.A systematic error was not detected.The spare part consumption of the concerned part is below the defined threshold.The incident described in the complaint is not classified as a reportable event after a thorough investigation as neither serious injury, death, nor unexpected prolonged hospitalization of the patient or other person occurred or is to be expected.

• Brand Name: AXIOM SENSIS HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 9422662
• MDR Text Key: 190836378
• Report Number: 3004977335-2019-07335
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1