Model Number ARD568370902 |
Device Problems
Break (1069); 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 02/28/2024 |
Event Type
malfunction
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Event Description
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On (b)(6) 2024 getinge became aware of an issue with one of surgical lights - powerled 700.It was stated the outer handle tube was broken.Photographic evidence confirmed that issue and indicated the headlight handle was broken with risk of missing particles, also the designated complaint unit employee found that headlight seal was damaged with 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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Manufacturer Narrative
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Event site name: (b)(6) hospital.Additional information will be provided following the conclusion of the investigation.H3 other text : device not returned to manufacturer.
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Search Alerts/Recalls
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