Model Number 10352127 |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Burn(s) (1757); Patient Problem/Medical Problem (2688)
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Event Date 02/17/2020 |
Event Type
Injury
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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 an adverse event occurred following examination on the magnetom essenza system.A patient reported a burn on the back of the left leg after a knee scan which resulted in a blister approximately 2 centimeters in diameter.The patient applied ointment and no further medical treatment was needed.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 completed an investigation of the reported event.Assessment does not indicate a system failure or malfunction and no non-conformity was identified.The patient was treated for a second degree burn with ointment under the supervision of the doctor and no further medical treatment was required.Siemens healthineers shenzhen clinical experts reviewed the patient's dicom images and no non-conformity was identified on the images.Review of the tune-up and qa reports was completed after the incident and the system is operating within specification.No system malfunction and no defect of the knee coil used was detected.The root cause for the patient injury could not identified.No further actions are planned by the manufacturer as no system malfunction was identified.
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Search Alerts/Recalls
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