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

Model Number 10094141

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2017

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.(b)(6).

Event Description

It was reported to siemens that a malfunction occurred with the artis zee biplane system.The user reported that water leaked from the joint of the x-ray tube cooling water circulation hose.There is no report of impact to the state of health of any patient or user involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.No root cause for the reported leak could be determined as neither the defective hose nor a picture showing the damage was made available for investigation.The service engineer checked the system and found the joint connecting the x-ray tube with the cooling water circulation hose to be leaking.The leakage was only drop by drop and could lead to a decreased water flow and loss of external tube cooling.This could compromise the imaging functionality due to limited x-ray tube capacity.No electrical shock is possible because the electrical connections in the affected area are completely covered.There are general measures to protect from electrical shock such as protective ground and no contact to a metal surface.No infection to the patient is possible because the x-ray tube as well as the fd is to be covered by sterile wrapping.This will protect fluid from coming into contact with the surrounding.The issue was resolved by exchanging the affected hose with the megalix water hose coupling repair kit and no further issues have been reported.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6861658
• MDR Text Key: 85991855
• Report Number: 3004977335-2017-93081
• 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: 08/21/2017

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: 10094141
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/21/2017
• Initial Date Manufacturer Received: 08/21/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 12/11/2017
• Supplement Dates FDA Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1