MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH AXIOM ARTIS ZEE FLOOR; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10094135

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Electric Shock (2554)

Event Date 01/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.This event occurred in (b)(6).

Event Description

It was reported to siemens that an adverse event occurred while operating the axiom artis zee floor system.Following a procedure, a nurse turned off the syringe pump and pulled the plug off the table.While holding the plug of the pump in one hand, she touched the infusion stand with her other hand and received an electric shock.It is not known at this time if medical treatment was provided.Additionally, we are unaware of any impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be an electro static discharge between nurse, infusion stand and table.A service engineer checked the affected system and no leakage current could be found.Earth measurements of the table and the accessories showed no abnormalities.The nurse reported "a kind of low level electrical shock".The most probable cause is an electro static discharge between the nurse, the infusion stand and the table.The reported electrical shock is not related to a malfunction of the artis zee system.No corrective action in the field is planned based on the present event.

• Brand Name: AXIOM ARTIS ZEE FLOOR
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 7269884
• MDR Text Key: 100117875
• Report Number: 3004977335-2018-00312
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K073290
• 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: 01/30/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2018
• Initial Date Manufacturer Received: 01/30/2018
• Initial Date FDA Received: 02/14/2018
• Supplement Dates Manufacturer Received: 04/11/2018
• Supplement Dates FDA Received: 04/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other