Model Number HM56003602 |
Device Problems
Crack (1135); Detachment of Device or Device Component (2907)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/21/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.
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Event Description
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On (b)(6) 2020 getinge became aware of an issue with one of surgical lights - hanaulux.The subject of the complaint is that part of spring arm's cover craced and detached.There was no injury reported however we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.
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Manufacturer Narrative
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Getinge became aware of an issue with one of surgical lights ¿ hanaulux 2003.The subject of the complaint is that part of spring arm's cover cracked and detached.There was no injury reported however, we decided to report the issue in abundance of caution as any parts falling off into sterile field or during procedure may lead to contamination.It was established that when the event occurred, the surgical light did not meet its specification as the cover cracked and detached and it contributed to the event.There is no information if upon the event occurrence, the device was or was not being used for patient treatment.The incident is due to an inappropriate use.The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.Additionally, the users are requested to pay attention to cracks in plastic parts.We believe that all remaining devices are performing correctly in the market.We also believe that if the manufacturer recommendation would have been followed the incident could have been avoided.
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Event Description
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Manufacturer's reference number (b)(4).
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Event Description
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Manufacturer's reference number: (b)(4).
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Manufacturer Narrative
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Additional information will be provided following the conclusion of the investigation.
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Search Alerts/Recalls
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