Model Number ARD569201917 |
Device Problems
Crack (1135); 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 Date 11/15/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Event site name: (b)(6).Contact person name: (b)(6).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 15th november, 2023 getinge became aware of an issue with one of surgical lights - powerled ii 700.It was stated the headlight upper cover was broken and cracked 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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Search Alerts/Recalls
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