Adverse event (AE) reporting and harms {22}
SYNDROME, EVENTS
All residents will be carefully monitored for the occurrence of AEs throughout the clinical investigation, from the first day to the completion of follow-up. The investigator or delegate will collect safety information using non-leading questions. Events directly observed or spontaneously volunteered by residents or caregiving staff will also be recorded throughout the clinical investigation. Clearly related signs, symptoms and abnormal diagnostic procedure results will be grouped together and reported as a single diagnosis or syndrome whenever possible. Any device-associated AE resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, misuse, operation or malfunction will also be collected and recorded in the eCRF.