Model Number ARD568370953 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/26/2023 |
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 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled 700i.It was stated that oil droplets were present under the stainless steel dust cover of the spring arm.According to the information provided by getinge technician there was a risk of oil dripping off the spring arm.We decided to report the issue in abundance of caution as any substance falling off into sterile field or during procedure may cause contamination.
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Event Description
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On 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled 700.It was stated that oil droplets were present under the stainless steel dust cover of the spring arm.According to the information provided by getinge technician there was a risk of oil dripping off the spring arm.We decided to report the issue in abundance of caution as any substance falling off into sterile field or during procedure may cause contamination.
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Manufacturer Narrative
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It appeared that the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00983) is a duplicate of the issue reported under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00984).Therefore, the issue is evaluated under manufacturer¿s reference number: (b)(4) (report number: 9710055-2023-00984).The correction of b5 describe event and problem deems required.This is based on the internal evaluation.Previous b5 describe event and problem: on 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled 700i.It was stated that oil droplets were present under the stainless steel dust cover of the spring arm.According to the information provided by getinge technician there was a risk of oil dripping off the spring arm.We decided to report the issue in abundance of caution as any substance falling off into sterile field or during procedure may cause contamination.Corrected b5 describe event and problem: on 26th november, 2023 getinge became aware of an issue with one of surgical lights - hled 700.It was stated that oil droplets were present under the stainless steel dust cover of the spring arm.According to the information provided by getinge technician there was a risk of oil dripping off the spring arm.We decided to report the issue in abundance of caution as any substance falling off into sterile field or during procedure may cause contamination.
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Search Alerts/Recalls
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