Device Problems
Detachment Of Device Component (1104); Component Falling (1105)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/21/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Ge healthcare investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.No report of patient involvement.Device evaluation anticipated, but not yet begun.
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Event Description
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On (b)(6) 2016, the user at (b)(6) hospital in (b)(6) reported that as they were positioning the dual crt monitor suspension on their prestige vh remote fluoroscopy device, the monitor detached from the monitor suspension and fell to the ground.This event occurred prior to a patient exam and no person was contacted by the monitor when it fell and therefore, 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 was determined to be degradation of the monitor¿s support feet due to age.The ge field engineer arrived at the site and identified all the support feet were crumbled.Upon investigation, it was determined the feet have been installed for approximately 15 years and therefore aged beyond their intended design life.The site was corrected by replacement of the monitor and support feet.This action was reported to fda per 21 cfr part 806 on 01-dec-2016.Ge healthcare has not yet received a corrections and removals report number regarding this action.
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Search Alerts/Recalls
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