The complaint has been reopened and reviewed according to fda form 483 inspectional observation ems #2, eobs2 from the fda inspection conducted between july 17 to july 21, 2022 at the ems and bonaduz sites.A detailed investigation was performed by an expert from the technical service: this issue is deemed a reportable event since the malfunction may lead to a delay of the therapy as the device has to be re-started.The root cause could not be identified since the startup issue is not reproducible.Within this investigation it has been confirmed that the device failed to meet its specifications at the time of the event.There was no patient or user harm.The allegation in this complaint was confirmed to be a complaint.No further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event similar to this issue as it will be deemed a reportable event.
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