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

Model Number 6623974

Device Problem Unexpected Shutdown (4019)

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

Event Date 02/02/2023

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported event.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed if additional information becomes available.

Event Description

It was reported to siemens that a malfunction occurred while operating the axiom sensis combo system.During a clinical procedure, the unit shutdown, and the user was unable to continue with the examination.The patient had to be moved to a different facility.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 healthcare completed the investigation of the reported event.The onsite service intervention showed that the problem was most likely caused by a defective hard drive disk (hdd) in the real time controller (rtc), which is responsible for signal processing.To resolve the problem, the rtc was replaced as a whole.The spare parts consumption of the defective hdd was checked.Any accumulation of faults or even a possible general fault that would require corrective action of the installed base could not be determined by the investigation.No further actions are needed for this complaint.The complaint has been closed.

• Brand Name: AXIOM SENSIS COMBO
• Type of Device: PROGRAMMABLE DIAGNOSTIC COMPUTER
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH-AT; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH-AT; siemensstr. 1 or rittigfeld 1; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: rebecca tudor ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 4843234198
• MDR Report Key: 16350978
• MDR Text Key: 309376213
• Report Number: 3004977335-2023-62394
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K150493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1