MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY AXIOM ARTIS ZEE CEILING; SYSTEM, XRAY, ANGIOGRAPHIC

Model Number 10094137

Device Problem Overheating of Device (1437)

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

Event Date 06/14/2016

Event Type  malfunction  

Manufacturer Narrative

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 a malfunction occurred while using the artis zee ceiling system.During a procedure, the system displayed an alert that the tube was hot.The procedure was terminated and the patient was safely transferred to an alternate system where the procedure was completed.The customer did not report any impact to the state of health of the patient involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Improper workmanship during installation and remote damage were identified as the root cause.The current plastic couplings have been exchanged by a metal version.Correction for this issue has been initiated via update ax004/15/s and was reported to the fda under 21 cfr 806; report (b)(4).This corrective action eliminates the root cause of the problem and prevents the possibility of reoccurrence.

• Brand Name: AXIOM ARTIS ZEE CEILING
• Type of Device: SYSTEM, XRAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• MDR Report Key: 5797827
• MDR Text Key: 50621686
• Report Number: 2240869-2016-03454
• 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: 07/14/2016

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: No Information
• Device Model Number: 10094137
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/15/2016
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1