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

Model Number 6634633

Device Problem Unexpected Shutdown (4019)

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

Event Date 07/17/2021

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 documentation screen went blank and rebooted.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.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The investigation could not provide a clear result as the system worked again after service intervention.The sensis system is equipped with several sub-components.One of them, namely the dmc (dialog monitor computer) restarted due to a temporary error.The rtc (real time controller) was not affected by this, and the vital signs were visualized to the user continuously.The technician from the local service organization went on site and eliminated the apparent temporary error by unplugging and plugging in the computer boards and installed the software system backup.The system then worked again as specified.Because the system has already reached "end of support" status and no spare parts are in stock nor can further service be ensured, the customer was informed in this regard.It is up to the operator to decide on the possible decommissioning or further use of the system.A possible general fault that would require corrective measures of the installed base could not be determined by the investigation.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: 12273321
• MDR Text Key: 264951922
• Report Number: 3004977335-2021-89726
• 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: 08/04/2021

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: 6634633
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/19/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1