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

Model Number 10094137

Device Problem Insufficient Information (3190)

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

Event Date 03/21/2018

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 a user suffered an adverse event following a procedure on the artis zee ceiling system.Following a procedure, when the exam room was being cleaned, a staff member received an electrical shock from the medrad injector.The electrical shock came from the blue turret portion of the medrad injector which was mounted to the table side.The user did not require any medical treatment.There is no report of impact to the state of health of any patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The reported electrical shock is not related to a malfunction of the artis zee system.A service engineer performed ground safety tests on the affected system.No leakage current could be found.Earth measurements of the table and the accessories showed no abnormalities.According to our factory experts the most probable root cause is an electro static discharge between device and operator.The reported electrical shock is not related to a malfunction of the artis zee system and no corrective action in the field is planned based on the present event.

• Brand Name: ARTIS ZEE CEILING
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 7407583
• MDR Text Key: 104711822
• Report Number: 3004977335-2018-22630
• 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,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

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: 10094137
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 06/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1