Additional information will be provided upon results of investigation.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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Getinge became aware of an issue with satelite device.As stated, there was corrosion detected on arms.No injury has been reported due to mentioned issue however we decided to report it in abundance of caution as such situation is related to the loss of paint integrity and can consequently cause a paint or rust particles falling into the sterile field and become a source of contamination.The getinge service technician, who visited the site, was able to address the issue.During investigation, it was concluded that the device involved did not meet the manufacturer¿s specification as a corrosion was detected on spring arms.At the time when the event occurred, the device was not being used for patient treatment and it contributed to the event.When reviewing similar reportable events for the same device type, we have been able to confirm that the investigated issue has never led to serious injury or worse.Despite our best efforts, the subject matter experts at the manufacturer did not receive enough information to conduct the technical investigation and deemed the root cause of the situation occurrence to be impossible to define.In case of new relevant information, the case will be reconsidered.Getinge shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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