BREATHING CIRCUIT SET

Additional Manufacturer Narrative

HAMILTON MEDICAL AG REFERENCE NUMBER: (B)(4). INVESTIGATION IS ONGOING. HMAG REFERENCE NUMBER: (B)(4) FDA REFERENCE: (B)(4).

Description of Event or Problem

IT WAS REPORTED TO HAMILTON MEDICAL AG, THAT: "REPORTING A KNOWN ISSUE WITH THE MANUFACTURING OF THE BREATHING CIRCUIT FOR HAMILTON T1. AFTER MOVING PATIENT FROM BEDSIDE VENTILATOR TO THE PORTABLE ONE, THE HAMILTON T1 STARTED ALARMING AND WAS UNABLE TO VENTILATE THE PATIENT. THE RESIDENT ANAESTHETIST CHANGED THE EXPIRATORY VALVE OF THE CIRCUIT WITH ANOTHER ONE AND THE ISSUE WAS RESOLVED. ACTIONS TAKEN AS PER THE FSN INSTRUCTIONS BY MANUFACTURER." PATIENT INVOLVEMENT AND MEDICAL INTERVENTION, BUT NO PATIENT, USER OR THIRD PARTY HARM WAS REPORTED.