Model Number ARD569201907 |
Device Problem
Temperature Problem (3022)
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Patient Problem
Burn, Thermal (2530)
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Event Date 03/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The issue is being investigated by manufacturing site.Device not returned to manufacturer.
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Event Description
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On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, customer said that patient had a dark spot on the skin exposed to the surgical light that wasn't there before the case.It was not established what exactly caused the discoloration however we decided to report the issue in abundance of caution as excessive heat from light head may lead to serious injury or worse.
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Manufacturer Narrative
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Issue is still being investigated by manufacturing site.
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Event Description
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Manufacturer's reference number (b)(4).
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Event Description
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Manufacturer reference number: (b)(4).
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Manufacturer Narrative
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Getinge became aware of an issue with one of surgical lights - powerled ii.As it was stated, customer said that patient had a dark spot on the skin exposed to the surgical light that wasn't there before the case.It was not established what exactly caused the discoloration however we decided to report the issue in abundance of caution as excessive heat from light head may lead to serious injury or worse.During investigation, it was found that device was not according to the manufacturer¿s specification.In the time when the event occurred, the device was being used for patient treatment and it contributed to the event.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse, to our knowledge.Unfortunately manufacturer did not receive enough information to conduct the technical investigation.It is not possible to determine the root cause and therefore the factory investigation report can not be performed.In case of new relevant information, the case will be reconsidered.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.The purpose of this submission is also to provide a correction of version or model# and catalog# sections.This is based on the result of receiving additional information #d4: previous version or model#: ard268400210a; corrected version or model#: ard569201907; previous catalog#: ard268400210a; corrected catalog#: ard569201907.
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Search Alerts/Recalls
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