MAUDE Adverse Event Report: SIEMENS HEALTHCARE ARTIS Q CEILING; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848281

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 10/18/2016

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.

Event Description

It was reported that a manufacturer or assembler of f1 quick connector cross threaded the two components resulting in a fluid leak.The connector could not be repaired due to the thread damage.The issue was found while investigating a leak post f1/f13 turn on.Siemens is unaware about 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 individual improper workmanship during service as the hoses had been tightened 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 Q CEILING
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE; siemensstrasse 1; forchheim 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6218333
• MDR Text Key: 63953691
• Report Number: 2240869-2017-58364
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K123529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2016

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: Health Professional
• Device Model Number: 10848281
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: 10/18/2016
• Supplement Dates FDA Received: 08/28/2017
• 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
• Patient Outcome(s): Other