SUNMED LLC

Description of Event or Problem

PATIENT DISCONNECTED FROM THE VENTILATOR AND PLACED ON AMBU BAG BY ANESTHESIA RESIDENT TEAM. PATIENT MOVED OUT OF OPERATING ROOM AND DOWN H HALLWAYS TO TRANSFER TO ICU. BETWEEN H AND G IT WAS NOTED THE PATIENT WAS DESATURATING AND THE VITAL SIGNS WERE BEGINNING TO DECOMPENSATE. AT THIS TIME, IT WAS NOTED THE AMBU BAG WAS NOT VENTILATING THE PATIENT. ALL CONNECTION AND OXYGEN SUPPLY WERE VERIFIED AND CHECKED. A RESIDENT RAN TO THE OPERATING ROOM TO GET A NEW AMBU BAG AND THE TEAM RUSHED THE PATIENT BACK INTO THE OPERATING ROOM. THE NEW AMBU BAG APPEARED TO FUNCTIONING PROPERLY. VENTILATION WAS VERIFIED BY AUSCULTATION AND HE WAS VENTILATED UNTIL OXYGEN SATURATIONS IMPROVED. THE PATIENT WAS THEN TRANSFERRED TO THE ICU WITHOUT ISSUE.

Additional Manufacturer Narrative

VENTILATION WAS COMPROMISED AND THE PATIENT WAS DEEMED HYPOXIC. THE BVM MALFUNCTIONING WOULD POTENTIALLY LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

Additional Manufacturer Narrative

VENTILATION WAS COMPROMISED AND THE PATIENT WAS DEEMED HYPOXIC. THE BVM MALFUNCTIONING WOULD POTENTIALLY LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET SUMMARY: RETURNED PRODUCT CONFIRMS COMPLAINT. PRODUCT WAS FOUND TO BE MISSING A DUCKBILL VALVE WHICH PREVENTED ANY PRESSURE TO BE DELIVERED TO THE PATIENT PORT. CUSTOMER NOTIFIED OF DEFECT, MITIGATION PROCESS OUTLINED IN IFU, AND DEFECT RATES. RA: RISK ASSESSMENT REVIEW OF RMA-20020, R37 IDENTIFIES THAT MISSING COMPONENTS (LIKE THE TAIL ASSEMBLY UMBRELLA VALVE) ARE ASSOCIATED WITH A SEVERITY OF 7.

Description of Event or Problem

PATIENT DISCONNECTED FROM THE VENTILATOR AND PLACED ON AMBU BAG BY ANESTHESIA RESIDENT TEAM. PATIENT MOVED OUT OF OR AND DOWN H HALLWAYS TO TRANSFER TO ICU. BETWEEN H AND G IT WAS NOTED THE PATIENT WAS DESATURATING AND THE VITAL SIGNS WERE BEGINNING TO DECOMPENSATE. AT THIS TIME, IT WAS NOTED THE AMBU BAG WAS NOT VENTILATING THE PATIENT. ALL CONNECTION AND OXYGEN SUPPLY WERE VERIFIED AND CHECKED. A RESIDENT RAN TO THE OR TO GET A NEW AMBU BAG AND THE TEAM RUSHED THE PATIENT BACK INTO THE OR. THE NEW AMBU BAG APPEARED TO FUNCTIONING PROPERLY. VENTILATION WAS VERIFIED BY AUSCULTATION AND HE WAS VENTILATED UNTIL OXYGEN SATURATIONS IMPROVED. THE PATIENT WAS THEN TRANSFERRED TO THE ICU WITHOUT ISSUE.