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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH ARTIS ZEE FLOOR; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 10094135
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/07/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number e2017017.(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 a malfunction occurred while operating the artis zee floor system.During an interventional procedure, the user reported the real time controller was not able to communicate and an error message appeared.The procedure was continued and completed on an alternate system.We are unaware of any impact to the state of health of the patient involved.Siemens has requested additional information in order to conduct an investigation of the reported event.
 
Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware failure.The investigation was performed on relevant hardware and additional information (i.E.Complaint description, log files, system history).The log file analysis showed that the system lost and regained connections to several sub components.As a result, the release of x-ray was practically blocked.This indicates an issue with the angio x-ray communication system (axcs) ethernet switch.The customer service employee replaced the damaged ethernet switch as well as the network cable.After hardware replacement there were no further issues reported.The manufacturer is not considering further actions resulting from this event as no systematic error has been recognized.
 
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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 Key8288366
MDR Text Key136920424
Report Number3004977335-2019-63826
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
PMA/PMN Number
K141574
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Repair
Type of Report Initial,Followup
Report Date 01/07/2019
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 Number10094135
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/07/2019
Event Location Hospital
Date Report to Manufacturer01/07/2019
Initial Date Manufacturer Received 01/07/2019
Initial Date FDA Received01/30/2019
Supplement Dates Manufacturer Received04/08/2019
Supplement Dates FDA Received04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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