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

Model Number 10280959

Device Problem Missing Value Reason (3192)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2018

Event Type  malfunction  

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 malfunction occurred while operating the artis zeego system.During an interventional procedure, the user reported that no x-ray was available.The patient was safely removed from the system and transferred to an alternate system where the procedure was completed.We are unaware of any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a malfunction within the x-ray generator.Investigation of the log files indicated that the invertor d510 showed the error "err_gen_imax" which points to a defective transistor (igbt module) on the affected pcb.If the system detects such failure in the intermediate circuit, any further release of x-ray is prohibited to avoid further damage in the x-ray production line.The service engineer replaced the affected invertor (d510) and the system was returned to full functionality.The manufacturer is not considering any further corrective actions at this time.

• Brand Name: ARTIS ZEEGO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 7258621
• MDR Text Key: 99991039
• Report Number: 3004977335-2018-14051
• 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: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10280959
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2018
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/09/2018
• 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