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

Model Number 6623974

Device Problem Failure to Power Up (1476)

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

Event Date 01/04/2021

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 system.During an interventional procedure, the user reported no contact with the signal input box upon powering on.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 detailed investigation showed that there was no malfunction of the system.The operation that took place did not correspond to the requirements of the system and was contrary to the procedure described in the instructions for use (ifu).It was clear from the log file that the shutdown sequence described in the ifu was not adhered to when the system was shut down the day before.As a result, the real-time computer (rtc) could not be booted the next time the device was switched on.In addition, the required system check was apparently not carried out before using the system, especially since the unavailability of the system was clearly indicated here.Our service department advised the customer by telephone and an orderly switch-off/on procedure immediately remedied the situation.The system works as specified.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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH- AT; siemensstrasse 1; forchheim, germany 91301 ; GM 91301
• MDR Report Key: 11164641
• MDR Text Key: 228841446
• Report Number: 3004977335-2021-62321
• 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: 01/13/2021

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: 6623974
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1