Model Number ARD568601997 |
Device Problem
Crack (1135)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided upon results of investigation.
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Event Description
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On (b)(6) 2020 getinge became aware of an issue with one of the light ¿ lucea 40.As it was stated the plastic casing of the lucea was broken.No information about any parts falling down was provided however we decided to report this case in abandoned of caution as the issue might have led to detachment of particles and consequently as potential risk.(b)(4).
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Manufacturer Narrative
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Getinge became aware of an issue with one of the light ¿ lucea 40.As it was stated the plastic casing of the lucea was broken.No information about any parts falling down was provided however we decided to report this case in abundance of caution as the issue might have led to detachment of particles and consequently as potential risk.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to event.None of the provided information indicate that upon the event occurrence the device was being used for patient treatment.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.Cover cracking is indicated by our product experts to likely be caused by combination of different factors such as: abnormal use or inappropriate cleaning and disinfection protocols.We believe that all remaining devices are performing correctly in the market.We also believe that if the preventive maintenance would have been followed the incident could have been avoided.Given the circumstances we shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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Event Description
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Manufacturer's reference number (b)(4).
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Search Alerts/Recalls
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