Model Number HM56003602 |
Device Problem
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 Type
malfunction
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Manufacturer Narrative
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Issue is being investigated by manufacturing site.It was observed during an external audit at getinge (b)(4), that servicing practices at getinge (b)(4) are not in compliance to applicable requirements due to identified gaps in quality management system.Specifically, unanticipated repair activities were not submitted as complaints and assessed for reporting as required per regulations and as a result this report was not submitted in a timely manner.Getinge (b)(4) has approved a comprehensive remediation plan and all unanticipated repair activities will be submitted as complaints.Device not returned to manufacturer.
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Event Description
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On 8th may, 2019 getinge became aware of an issue with one of surgical lights - hanaulux 2003.As it was stated, the headlight had detached due to damaged spring arm.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 or cause injury due to its own weight.
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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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The issue is being investigated by the manufacturing site.
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Manufacturer Narrative
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On (b)(6) 2019 getinge became aware of an issue with one of surgical lights - hanaulux 2003.As it was stated, the headlight had detached due to damaged spring arm.There was no injury reported however we decided to report the issue based on the potential as any parts falling off into sterile field or during procedure may lead to contamination or cause injury due to its own weight.It was established that when the event occurred, the surgical light did not meet its specification due to the detachment of headlight caused by damaged spring arm and it contributed to the issue.It is unknown if the device was being used for patient treatment.During the investigation it was found that the reported scenario has never lead, to date, to serious injury or worse.The manufacturer¿s subject matter experts have investigated the issue.It was concluded that the breakage has been caused by a tearing of the spring arm tube on the edge of the welding joint.The contributing factors are excessive or repetitive mechanical stresses, intensive use.To prevent any similar incident, the manufacturer has modified the spring arm design by increasing the thickness of the tube.In (b)(6) 2017 a field action plan has been launched to replace all the ac2000 spring arms with old design and for all range of lights involved.This action plan is detailed in the field safety notice (b)(4)2018 ac 2000 spring arm which is ongoing.We believe that currently and overall, the related devices are performing correctly in the market with regards to the reported issue.
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Event Description
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Manufacturer reference number: (b)(4).
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Search Alerts/Recalls
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