Model Number ARDVST229029A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/13/2018 |
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 ne of surgical lights- volista.As it was stated, the screws of spring arms are loosening and there is a risk that they could fall into the open wound.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.
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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.(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.(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 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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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- volista.As it was stated, the screws of spring arms were loosening and there was a risk that they could fell into the operation theatre.There was no injury reported however we decided to report the issue in abundance of caution as any particle falling might be a source of contamination.It was established that when the event occurred, the surgical light did not meet its specification and it contributed to the event.There is no information if during the event occurrence the device was or was not being used for patient treatment.The loosening of the screws was considered by product specialists at the manufacturer to most likely have been caused by lack of inspection during the maintenance.To prevent the loosening and the fall of the screw, the user manual indicates to check all the fixing screws and to check the hold of the spring arm covers.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.Given the circumstances and the fact that this is the fourth complaint of this nature 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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Search Alerts/Recalls
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