Model Number 781196 |
Device Problem
Unintended System Motion (1430)
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Patient Problems
Death (1802); Injury (2348)
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Event Date 01/27/2018 |
Event Type
Death
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Manufacturer Narrative
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The investigation is still ongoing on this event.When the investigation is completed a follow-up will be sent to the fda.
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Event Description
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Philips received a report related to a serious attraction incident with an achieva 1.5t system.A man was attending an elderly relative (patient) and was carrying an oxygen cylinder for the patient into the mri room.The cylinder was attracted to the magnet resulting into severe injuries to the person bringing in the oxygen cylinder.The injured man was removed from the magnet and transferred to the er where he died as result of his injuries.
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Manufacturer Narrative
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This event was due to not following mri safety standards by bringing a oxygen cylinder with magnetic material into the mr examination room.It is known that magnetic materials should not be brought into the examination room.The safety directions as presented in the instruction for use already contain warnings on this matter.
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Search Alerts/Recalls
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