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 almost 3 years ago, no attempts will be performed 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 similar to 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 at the time of the event while the ventilator was not under ventilation.As per the operator, the root cause was determined to be ethernet error.The te246012 indicated that the ventilator checked for an ethernet connection at post (power on self-test) and does not find it due to lose of connection.In consequence the unit did not alarmed after restarting.The device worked properly.The issue was solved.There was no patient or user harm.
|
This c2 was turned on for use in the patient, but a "te 232056" "self test failed" occurred.Because ventilation could not be started due to the influence of this phenomenon, another c2 was substituted.The patient was not hurt because the replacement was completed immediately.I checked with the user and the hepa filter was replaced 2 months ago.Please tell me the cause and countermeasure of this phenomenon.
|