MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS ZEE FLOOR; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10094135

Device Problem Use of Device Problem (1670)

Patient Problems Death (1802); Sudden Cardiac Death (2510)

Event Date 12/11/2018

Event Type  Death  

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.This event occurred in (b)(6).Resubmission of initial report due to report code error.

Event Description

It was reported to siemens that an adverse event occurred while operating the artis zee floor system.During a routine cardiac procedure, the patient went into cardiac arrest.The operator attempted to press the "emergency medical assistance" button on the wall of the exam room but pressed the "emergency stop" button instead.When the "emergency stop" button was activated, all electrical power to the artis zee floor system was stopped.Cpr was administered to the patient while the system table was moved manually.It was reported that the patient passed away.The patient's previous medical history is not known at this time.Additional details have been requested for investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.The root cause was determined to be a user error.It was determined that the system had no impact on the patient outcome.During a routine cardiac procedure a patient suffered cardiac arrest on the patient table.As a result, the radiographer went to operate the "emergency medical assistance red button" but inadvertently engaged the "emergency off red button" of the system which interrupts all electrical power of the siemens artis fc.In order to perform cpr, the c-bow was manually rotated away from the patient table.After restoring the energy, the c-arm was moved and it collided with a small foot stool and activated the collision safety switch.This collision caused damage to the tube cover and a disconnection of a plug (h11.X4) inside the tube housing.This was proven by log file analysis which shows that after movement of the c-arm the safety switch and the oil pressure switch of the x-ray tube were activated at exactly the same time.The system is equipped with a number of safety mechanisms (e.G.Dead man's grip, collision computer and sensor, emergency stop buttons) which help prevent collisions during unit movements.Additionally, the operator manual contains adequate instructions on how to move the system without colliding with obstacles.As no system error has been detected and the problems mentioned in the complaint were caused by the operator; a user error in handling the system could be determined as the root cause.The affected connector has been reseated by the local service organization and the error did not reoccur.The manufacturer is not considering further actions resulting from this event as no system error has been recognized.

• Brand Name: ARTIS ZEE FLOOR
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forccheim, germany 91301 ; GM 91301
• MDR Report Key: 8482664
• MDR Text Key: 140908526
• Report Number: 3004977335-2018-61121
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K141574
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10094135
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2018
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death