MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY ARTIS ZEE BIPLANE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10094141

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 09/09/2016

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 the (b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the artis zee biplane system.The customer reported water leakage from the x-ay tube cooling water coupling at the x-ray side.The water was leaking from the covers.We are unaware of any 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 individual improper workmanship during service as the hoses had been tightend during x-ray tube replacement in a way such that the bending radius was permanently below the critical value.In case of a malfunction of the x-ray tube cooling unit, a multi-stage detection and warning mechanism is activated so that the system displays the message "tube hot, have a break" for the user.If, despite the messages, the user continues x-ray imaging, a hw switch is activated and disables x-ray imaging.The system displays the message "no xray, tube too hot".

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6253178
• MDR Text Key: 65349279
• Report Number: 2240869-2017-05347
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 09/13/2016

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: 10094141
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2016
• Initial Date FDA Received: 01/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1