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

Model Number 10094137

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 01/25/2018

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 during service activities on the axiom artis zee ceiling system.During a reactive service call related to drifting of the large display extended dcs, a sheared bolt that mounts the main rotation arm to the ceiling frame was found.The service engineer observed approximately a 4mm space on one side and contact with the chasis on the opposite side.Use of the system was suspended until repairs can be performed.There is no report of impact to the state of health of any patient or operator involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a component failure.The investigation revealed that the cause of the error was due to the preload force of the dcs mounting bolts decreasing over time.Siemens has developed a solution which has successfully completed endurance testing.The affected part has been exchanged by the local service organization and the error did not reoccur.A field safety corrective action (fsca) ax023/18/s is planned to be released in the second quarter of 2019 and will be reported to the fda under 21 cfr part 806.

• 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: 7291667
• MDR Text Key: 101134096
• Report Number: 3004977335-2018-14682
• 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: Repair
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

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: 10094137
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2018
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/23/2018
• Supplement Dates Manufacturer Received: 09/25/2018
• Supplement Dates FDA Received: 09/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1