MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEEGO; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10280959

Device Problem Use of Device Problem (1670)

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

Event Date 08/14/2018

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.

Event Description

It was reported to siemens that an adverse event occurred following use of the artis zeego system.During room cleaning, the user was touching the detector with one hand while bending over and removing the plastic tube drape with his other hand.The user stated that he felt a shock sensation in his hand and arm of which was in contact with the detector.It is not known at this time if medical treatment was needed.Additional details have been requested for investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.No system failure or malfunction and no non-conformity were identified.The investigation showed that an electrical shock by line power could be excluded.The part touched (plastic cover) is insulated and no metal parts are reachable and therefore, no current flow is possible.Furthermore, the system has been checked on site and all ground resistance tests have passed successfully.The system works as specified.As no conductive materials have been touched and the system works as specified, no electrical shock could have been occurred.The shock reported is most likely an electrostatic discharge which can happen if a person is wearing synthetics.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.

• Brand Name: ARTIS ZEEGO
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 8482589
• MDR Text Key: 140903300
• Report Number: 3004977335-2018-44470
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K141574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10280959
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/15/2018
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other