MAUDE Adverse Event Report: SIEMENS SHENZHEN MAGNETIC RESONANCE LTD. ARTIS ONE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10848600

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Death (1802)

Event Date 12/28/2018

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.

Event Description

It was reported to siemens that an adverse event occurred while operating the artis one system.During an emergency procedure, the patient's condition was deteriorating and doctors were performing resuscitation when the system power shut down.It was reported that the patient passed away due to their poor health condition.The main breaker was reset and the power was restored.Siemens has requested additional information in order to conduct an investigation of the reported events.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the event does not indicate a system failure or malfunction and no non-conformity was identified.The investigation was performed considering complaint description, system log files and system history.The analysis of the log files showed the system was working as specified without error before the system shut down.The system was hard powered off on (b)(6) 2018 06:06:01, and rebooted up again at (b)(6) 2018 06:27:03.Following the restart, the system was working as specified.In the last position of the system, the operator was able to perform patient resuscitation.System design allows manual movements to be used when patient rescue is hindered, eg.Stand can be moved manually by activating unlocking pushbutton at the backside of the stand column; patient table can be rotated and table top can be moved in longitudinal or transversal direction with reasonable force.According to information from service and the hospital main power supply diagram, the 125amp breaker was tripped which could potentially be caused by the following: a possible short circuit in the artis one system cabinet or generator cabinet.If there was short circuit in the system cabinet or generator, the problem would be permanent and some damage mark/parts in the system cabinet/generator cabinet would be found.According to the power diagram, the short voltage was 277 vdc.The system was investigated and no defect or damaged parts were found during trouble shooting by the service engineer.The system power was monitored for several weeks with line analyzers installed after the event.The system works as specified and the issue was not reported again.The data from the line analyzer did not show any abnormalities.Therefore, the potential cause of a short circuit in the artis one system was excluded.The epo(emergency power off) was pressed to trip the main breaker by accident.According to the hospital power supply diagram, once the epo(emergency power off) was pressed, it would result in the 125amp breaker trip.The system was investigated and this was confirmed and reproduced by the local service engineer during site simulation.After the epo and breaker reset, the system could be turned on again.Considering the patient was undergoing resuscitation efforts, it is strongly suspected that the epo was reached/pressed at that time by accident.The system power down did not interrupt the patient resuscitation, no system defects were found, and it is inferred that the system hard power-off was caused by the accidental pressing of the epo.

• Brand Name: ARTIS ONE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.; gaoxin c ave.; 2nd, hi-tech industrial park; shenzhen, china 51805 7; CH 518057
• MDR Report Key: 8247410
• MDR Text Key: 133039675
• Report Number: 3004754211-2019-63075
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K133580
• 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: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10848600
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/03/2019
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 02/28/2019
• Supplement Dates FDA Received: 02/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death