Model Number ARDPWT259215A |
Device Problems
Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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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 (b)(6) 2023 getinge became aware of an issue with one of surgical lights - powerled ii.It was stated the inner seal has pulled away from the corner allowing moisture into the light panels causing streaking and debris internally.Based on photographic evidence particles may be missing from the seal.We decided to report the issue in abundance of caution as contact of water with live parts may cause electric shock and particles falling off into sterile field or during procedure may cause contamination.
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Search Alerts/Recalls
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