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 "switch on safety mode due to tf 341009" can lead to a delay in the therapy since the ventilator cannot be used.Eventually a new ventilator needs to be prepared.The root cause of the switch on safety mode was determined to be an unintended use of the suctioning tool in conjunction with a closed suctioning system having as effect an incorrect interpretation of the situation.The correction in this case was to strictly follow the instruction for use.With this investigation it has been confirmed that the device failed to meet its specifications at the time of the event, while the medical device was used for treatment (in ventilation phase).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 like this issue as it will be deemed a reportable event.
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