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U.S. Department of Health and Human Services

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

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SIEMENS HEALTHCARE GMBH ARTIS ICONO BIPLANE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM Back to Search Results
Model Number 11327600
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/23/2021
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 artis icono biplane system.During an interventional procedure, the user reported that the system could not be used when there is no communication between the ias/ ivs* and the mca*.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.*ias/ ivs- image acquisition system/ image visualization system.*mca- modality computing architecture hw.
 
Manufacturer Narrative
Siemens has completed an investigation of the reported event.The root cause was determined to be a hardware error.The investigation was performed considering complaint description, cs reports, system history, and system log files.The investigation of log files shows that during the procedure the system entered backup review mode with limiting post processing functionality due to an image visualization system (ivs) host channel adapter (hca) printed wiring board issue.This means that due to the hca board issue the system switched to the "backup review mode", as it is intended for such cases, which is a mitigating factor for this issue.In this mode, radiation is available, and the images can also be displayed on the monitor in the examination room, but these images cannot be transferred to the ivs as desired and not further processed or sent on.If the problem was temporary only, all images would have been automatically transferred to the ivs after a restart and could have been processed further.In this case, however, this was not possible due to the ivs defect.The customer service engineer (ces) replaced the hca board and the fiber optical cable.After hardware replacement there were no further issues reported and the system works as intended.The occurrence rate of the identified cause has been checked and no error accumulation has been identified.The occurrence rate is below the defined threshold, therefore, no corrective action is necessary.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
ARTIS ICONO BIPLANE
Type of Device
INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemensstr. 1
forchheim, germany 91301
GM  91301
MDR Report Key12120188
MDR Text Key262446307
Report Number3004977335-2021-86312
Device Sequence Number1
Product Code OWB
UDI-Device Identifier04056869063317
UDI-Public04056869063317
Combination Product (y/n)N
PMA/PMN Number
K193326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Remedial Action Repair
Type of Report Initial,Followup
Report Date 07/06/2021
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 Number11327600
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/23/2021
Initial Date FDA Received07/06/2021
Supplement Dates Manufacturer Received08/06/2021
Supplement Dates FDA Received08/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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