Model Number 11291455 |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported to siemens that a malfunction occurred while operating the magnetom sola system.During a cardiac study, the user reported that the system hung up, and the study had to be repeated.It is not known if additional contrast was administered.At this time, 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.
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Manufacturer Narrative
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Siemens has attempted an investigation of the reported event.It was stated in the complaint, that the system crashed during a cardiac study with contrast agent.The only way to continue was restarting the whole system which made it necessary to reinject contrast.The data available in this potential complaint does not contain sufficient information to conduct an investigation.Siemens was made aware on november 4, 2020 that the system received a software update and the savelog that is essential for the investigation is not available.
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Search Alerts/Recalls
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