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

Model Number 6634633

Device Problems Power Problem (3010); Unexpected Shutdown (4019)

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

Event Date 02/14/2023

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 an adverse event occurred while operating the sensis hemo low system.During a procedure, the system turned off and would not restart immediately.The user had to turn the key switch on and off multiple times.After several attempts, the sensis unit booted up normally and the examination could be continued.However, the user reported that at that point the patient was already deceased.The customer confirmed that the patient passed away prior to the system failure.Siemens has requested additional information in order to conduct an investigation of the reported event.

Manufacturer Narrative

The detailed investigation of the log files confirmed that the system had shut down unexpectedly.According to experts, the likely root cause was a hardware failure of the uninterruptible power supply unit (ups).The affected ups was replaced by siemens service organization.The reported error has not re-occurred since the part replacement.The spare parts consumption of the defective power supply 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.There is no indication that the sensis system caused or contributed to the patient's death, as the error occurred after the patient passed away, which was confirmed by the user.The reported incident was not classified as a reportable event after the detailed investigation as neither serious injury, death nor an unexpected prolonged hospitalization of the patient or any other person could be expected, since the corresponding probability according to the risk analysis is in the range of inconceivable.

• Brand Name: AXIOM SENSIS HEMO LOW
• 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; siemenstrasse 1 or; rittigfeld 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: anastasia sokolova ; liberty blvd 40; mc 65-1a; malvern, PA 19355 ; 4843234897
• MDR Report Key: 16397154
• MDR Text Key: 310163871
• Report Number: 3004977335-2023-63882
• 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,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2023
• 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