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Device Problems
Detachment Of Device Component (1104); Component Falling (1105); Noise, Audible (3273)
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Patient Problems
No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Ge healthcare's investigation is ongoing.A follow-up report will be submitted once the investigation has been completed.
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Event Description
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On (b)(6)2017, the technologist at (b)(6) in the united states reported they heard a loud noise that came from the radiology exam room.When the technologist investigated the noise, they identified the crt monitor detached from the monitor suspension and was hanging from the suspension by the power cables.There was nobody within the exam room when the monitor fell and there was no injury related to this event.
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Manufacturer Narrative
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Ge healthcare¿s investigation has completed and the root cause of the crt monitor detaching was determined to be degradation of the monitor¿s support feet due to age.The site was corrected through replacement of the newly designed metal monitor support feet.No further actions are needed.During investigation, it was also identified this monitor suspension was not included in the original customer installed base list related to corrections and removals report number 3007734888-12/01/16-001-c.It was determined this monitor suspension was de-installed at another site by a third party and therefore removed from ge installed base tracking.(b)(6) clinic stated they had purchased the monitor suspension from a third party who also installed the suspension.Since ge healthcare does not perform the service maintenance at (b)(6) clinic and was not made aware of the third-party installation, it was not included in the corrections and removal customer installed base list.This monitor suspension has since been added to ge healthcare's installed base tracking.No further actions are needed.This action was reported to fda per 21 cfr part 806 on 01-dec-2016 through corrections and removals report number 3007734888-12/01/16-001-c.
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Search Alerts/Recalls
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