SUNMED HOLDINGS LLC

Description of Event or Problem

THE PATIENT WAS IN CRITICAL CONDITION IN THE ICU REQUIRING EMERGENT INTUBATION. FOLLOWING ADMINISTRATION OF RSI DRUGS, BVM VENTILATION WAS CARRIED OUT WITH NOTED CHEST RISE THIS WAS THE FIRST USE FOR THE RESUSCITATION BAG. THE PATIENT WAS INTUBATED AND VENTILATION WAS RESUMED WITH RESUSCITATION BAG. THE PATIENT THEN BEGAN TO DETERIORATE SUDDENLY. OXYGEN SATURATION WAS DECREASING AND BREATH SOUNDS COULD NOT BE VERIFIED. THERE WAS NO CHEST RISE. THE ENDOTRACHEAL TUBE WAS VISUALIZED TO BE IN PROPER POSITION. IT WAS NOTED THAT THERE WAS NO PRESSURE REGISTERING ON THE MANOMETER WHILE SQUEEZING THE RESUSCITATION BAG. THE BAG WAS DISCONNECTED AND THE BAG WAS SQUEEZED WHILE OCCLUDING PATIENT PORT. AGAIN, THERE WAS NO PRESSURE MEASUREMENT ON THE MANOMETER. STAFF OBTAINED A REPLACEMENT RESUSCITATION BAG AND RESUMED VENTILATION WITH IMMEDIATE IMPROVEMENT IN THE PATIENT CONDITION AND CHEST RISE AND BILATERAL BREATH SOUNDS WERE VERIFIED. PATIENT WAS STABILIZED AFTER APPROXIMATELY 2 MINUTES OF TROUBLESHOOTING AND TIME TO OBTAIN REPLACEMENT RESUSCITATION BAG. THERE WAS NO PRESSURE REGISTERING ON THE MANOMETER WHILE SQUEEZING THE RESUSCITATION BAG.

Additional Manufacturer Narrative

THE RESUSCITATOR HAD NO PRESSURE REGISTERING ON THE MANOMETER WHILE SQUEEZING THE RESUSCITATION BAG. THIS WAS AN INTERRUPTION IN RESUSCITATION EFFORTS. THE CLINICIAN WAS UNABLE TO PROVIDE VENTILATION TO THE PATIENT AND HAD TO GET A REPLACEMENT RESUSCITATION BAG.

Description of Event or Problem

THE PATIENT WAS IN CRITICAL CONDITION IN THE ICU REQUIRING EMERGENT INTUBATION. FOLLOWING ADMINISTRATION OF RSI DRUGS, BVM VENTILATION WAS CARRIED OUT WITH NOTED CHEST RISE THIS WAS THE FIRST USE FOR THE RESUSCITATION BAG. THE PATIENT WAS INTUBATED AND VENTILATION WAS RESUMED WITH RESUSCITATION BAG. THE PATIENT THEN BEGAN TO DETERIORATE SUDDENLY. OXYGEN SATURATION WAS DECREASING AND BREATH SOUNDS COULD NOT BE VERIFIED. THERE WAS NO CHEST RISE. THE ENDOTRACHEAL TUBE WAS VISUALIZED TO BE IN PROPER POSITION. IT WAS NOTED THAT THERE WAS NO PRESSURE REGISTERING ON THE MANOMETER WHILE SQUEEZING THE RESUSCITATION BAG. THE BAG WAS DISCONNECTED AND THE BAG WAS SQUEEZED WHILE OCCLUDING PATIENT PORT. AGAIN, THERE WAS NO PRESSURE MEASUREMENT ON THE MANOMETER. STAFF OBTAINED A REPLACEMENT RESUSCITATION BAG AND RESUMED VENTILATION WITH IMMEDIATE IMPROVEMENT IN THE PATIENT CONDITION AND CHEST RISE AND BILATERAL BREATH SOUNDS WERE VERIFIED. PATIENT WAS STABILIZED AFTER APPROXIMATELY 2 MINUTES OF TROUBLESHOOTING AND TIME TO OBTAIN REPLACEMENT RESUSCITATION BAG. THERE WAS NO PRESSURE REGISTERING ON THE MANOMETER WHILE SQUEEZING THE RESUSCITATION BAG.

Additional Manufacturer Narrative

THE RESUSCITATOR HAD NO PRESSURE REGISTERING ON THE MANOMETER WHILE SQUEEZING THE RESUSCITATION BAG. THIS WAS AN INTERRUPTION IN RESUSCITATION EFFORTS. THE CLINICIAN WAS UNABLE TO PROVIDE VENTILATION TO THE PATIENT AND HAD TO GET A REPLACEMENT RESUSCITATION BAG. 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.