Catalog Number ARD568601997 |
Device Problem
Crack (1135)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The issue is being investigated by manufacturing site.(b)(4).
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Event Description
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On (b)(4) 2018 maquet (b)(4) became aware of an incident with one of surgical lights- lucea.As it was stated, the lights are cracking on the screws and there is a possibility that the particles could fall.There is no injury reported however we decided to report the issue in abundance of caution as any particle falling might be a source of contamination.(b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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Event Description
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(b)(4).
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Manufacturer Narrative
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The issue is still being investigated by manufacturing site.
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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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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(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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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(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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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(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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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(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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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(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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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(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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The issue is still being investigated by manufacturer's site.(b)(4).Exemption # e2018005.(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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The issue is still being investigated by manufacturing site.(b)(4).Exemption # e2018005.(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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The issue is still being investigated by manufacturing site.
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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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The issue is still being investigated by manufacturing site.
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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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(b)(4).Exemption # e2018005.(b)(4).The issue is still being investigated by manufacturing site.
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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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The issue is still being investigated by manufacturing site.
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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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The issue is still being investigated by manufacturing site.
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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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The issue is still investigated by manufacturing site.(b)(4).Exemption # e2018005.(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 incident with one of surgical lights- lucea 40.As it was stated, the lights are cracking on the screws and there was a possibility that the particles could fall.There is no injury reported however we decided to report the issue in abundance of caution as any particle falling might be a source of contamination.The investigation into the root cause of the problem occurrence has been performed and concludes that the most likely root causes of the breakage of the cover and, consequently, particles of cover detachment are repetitive shock during use or incompatible cleaning products.In summary and based on the information available to date, when the event occurred, the device was not being used for the patient treatment but it did play a role in the reported event.Performed evaluation of the involved device allowed to establish that it failed to meet the manufacturer specification.Although no injury occurred as a result of this event it was decided to report based on the potential and in abundance of caution.Given the circumstances and the fact that the issue is found to be isolated event getinge does not propose any further action at this time.
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Event Description
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Manufacturer reference number 180465.
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Search Alerts/Recalls
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