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Model Number ARD568350900 |
Device Problems
Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
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Event Description
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On 21st august, 2023 getinge became aware of an issue with one of surgical lights - powerled.It was stated the dome control lexan is damaged with possibility of missing particles.We decided to report the issue in abundance of caution as any particles falling off into sterile field or during procedure may cause contamination.
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Search Alerts/Recalls
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