Model Number ARD568601998 |
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 11/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter was hospital technician.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 20th november, 2023 getinge became aware of an issue with one of examination lights - lucea 40.It was stated the upper fixing point of the transparent shell was broken.The designated complaint unit employee confirmed based on photographic evidence the headlight cover at the attachment point of the upper headlight covers was cracked with missing particles.We decided to report the issue in abundance of caution as any particles falling off during examination procedure may cause infection.
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Search Alerts/Recalls
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