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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH- AT AXIOM ARTIS DTA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

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SIEMENS HEALTHCARE GMBH- AT AXIOM ARTIS DTA; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 7008605
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/11/2021
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 to siemens that a malfunction occurred while operating the axiom artis dta system.During an emergency procedure, the user reported a "no connection" message on the data display and no system movements were possible.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 data communication problem.During investigation, it was determined that the ethernet switch of the network had a defect.Unfortunately, the network switch was disposed of by the customer, and it was not available for further investigation.Based on the available information, the on-site technician as well as the technical specialists agree that the defective ethernet switch was the cause of the problem.This thesis is also supported by the fact that after replacing the component, the system worked as specified and the original error has not been reported again.A possible general error that would require corrective measures of the installed base could not be determined by the investigation.After detailed investigation, the incident is not classified as a reportable event as neither serious injury, death nor an unexpected, prolonged hospitalization of the patient or any other person occurred or could be expected.
 
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Brand Name
AXIOM ARTIS DTA
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH- AT
siemensstrasse 1
forchheim, germany 91301
GM  91301
MDR Report Key11342146
MDR Text Key232640508
Report Number3004977335-2021-68006
Device Sequence Number1
Product Code OWB
Combination Product (y/n)N
PMA/PMN Number
K052202
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Inspection
Type of Report Initial,Followup
Report Date 02/18/2021
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 Number7008605
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/11/2021
Initial Date FDA Received02/18/2021
Supplement Dates Manufacturer Received06/01/2021
Supplement Dates FDA Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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