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

Model Number 6634633

Device Problems Loose or Intermittent Connection (1371); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

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 signal acquisition errors.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 was determined to be a hardware error.The logfiles showed several balance pressure attempts during an ongoing procedure without success.The issue was not resolved and it is unknown what exact troubleshooting steps were performed by the customer.Signal acquisition errors were seen, however, expert opinion is that during troubleshooting, the customer tried reseating some cables which led to disconnects.After closing and reopening study events, the user decided to relocate the patient.The customer service engineer was not able to perform troubleshooting activities as the customer was using the system at the time.It was recommended to replace the intermittent failing pwb as soon as possible to prevent recurrence of the issue.The customer was made aware of the risks if the problem reoccurs.Addiionally, it was recommended to shut down and reboot the system regularly more often (once a week) which is also part of the operator manual.The last reboot was 28 days before the issue occurred.The operator manual contains the following recommendation in chapter "switching on and off"."we nevertheless recommend that you shut down and reboot your system once a week." a reboot of the sensis system was performed at a later time and it is assumed that this resolved the issue temporarily.Log file analysis clearly indicate a faulty hemo printed wiring board (pwb) which is responsible for processing temperatures, spo2 and connects the hemomed adapter where the internal blood pressures are attached to.There was no harm reported to the patient.An extensive investigation could not be performed as the hemo board was not replaced and not returned for a detail investigation.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold and no field corrective action is necessary.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person occurred or could be expected.

• Brand Name: AXIOM SENSIS HEMO LOW
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 10553563
• MDR Text Key: 207551249
• Report Number: 3004977335-2020-45397
• 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,user f
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1