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

Model Number 6634633

Device Problem Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Reporting facility phone number is: (b)(6).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 upon completion of the investigation.

Event Description

It was reported to siemens that a facility employee received an electrical shock when cleaning the reported system.The employee was checked with an ecg at the hospital the same day and again in the evening after receiving the electrical shock.The current health status of the employee is good, with no adverse issues present.The reported event occurred in (b)(6).

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.Information was received that a cleaning staff member received an electric shock while cleaning under the patient table.After a thorough investigation, an electric shock in the actual sense (mains voltage) was largely ruled out when the system was inspected and tested on site.Any leakage current or malfunction was not detected, and the system works as specified.According to the system specialists, a static discharge is much more likely.This is confirmed by the fact that the person concerned was medically examined and found fit for work.However, even if we assume that no electric shock in the conventional sense occurred, it should be noted, that the system was cleaned under voltage.This is prohibited for both the artis system and the sensis system, especially since liquids penetrating electrical systems entail a certain potential of danger.Corresponding descriptions can be found in the instruction for use (ifu) of the respective system.A possible general error which would require corrective action of the installed base could not be identified 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
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH - AT; siemensstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 11067169
• MDR Text Key: 223589940
• Report Number: 3004977335-2020-59834
• 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: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 12/08/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 02/26/2021
• Supplement Dates FDA Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other