Any authorised equipment user, Department Manager, Biomedical Engineer, and Maintenance Technician.
Steps
1If a device may be unsafe, stop using it and follow the local clinical-safety and manufacturer guidance immediately.
2Apply the organisation’s physical tag, isolation, backup-equipment, and escalation procedure. Do not rely only on a software status.
3Create a maintenance request with the equipment, fault description, observed effect, date and time, location, reporter, urgency, and patient-safety impact without recording unnecessary patient information.
4Assign or notify the responsible biomedical team and capture the initial containment action.
5Escalate an adverse incident, suspected device defect, or reportable event through the organisation’s incident and regulatory process.