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: since the complaint in question was submitted to hamilton medical ag more than two years ago, no attempts will be made to obtain additional information.No further investigation or correction will be performed except those mentioned above.In future hamilton medical ag will report an event like this issue as it will be deemed a reportable event.The allegation in this complaint was confirmed to be a complaint.With this investigation it has been confirmed that the device failed to meet its specifications while the ventilator was turned on.The most probable root cause is an ram initialization problem during startup which was resolved with sw2.2.4.A restart of the ventilator resolved the issue.A sw update to version 2.2.4 was recommended.There was no patient or user harm reported.
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