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 Problem Death (1802)

Event Date 12/22/2018

Event Type  Injury  

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.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 patient resuscitation, the user pressed the "emergency power off" button that disconnects the equipment from the hospital and ups power.The user was able to continue resuscitation on the patient during the attempt to restore power, however, it was reported that the patient passed away during resuscitation efforts.The patients prior medical history or condition is not known at this time.Siemens has requested additional information in order to conduct an investigation.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Assessment of the reported incident does not indicate a system failure or malfunction and no non-conformity was identified.The customer stated that the patient expired due to their current health condition and not as a result of the system.The event of pressing the emergency power off and delay of restoring power did not impact the treatment of the patient.No parts were exchanged and the system works as specified.The manufacturer is not considering further actions resulting from this event as no systematic 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: 8482658
• MDR Text Key: 140906752
• Report Number: 3004977335-2018-62692
• 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,user f
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 12/22/2018

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
• Is this a Product Problem Report?: No
• 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: 12/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2018
• Date Manufacturer Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death