MANUAL RESUSCITATOR WITH MANOMETER

Description of Event or Problem

PATIENT PRESENTATION: AN UNRESPONSIVE PATIENT, POST CARDIOPULMONARY ARREST, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 3, INDICATIVE OF SEVERE CONSCIOUSNESS IMPAIRMENT. MEDICAL INTERVENTIONS: RAPID SEQUENCE INTUBATION (RSI) WAS PERFORMED TO ESTABLISH AIRWAY PATENCY. THE ENDOTRACHEAL TUBE (ETT) WAS VENTILATED WITH AN ADULT SUNMED (AF1100MB-P) MANUAL RESUSCITATOR WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 15 CMH2O, HEAT AND MOISTURE EXCHANGE FILTER (HMFE), IN-LINE END-TIDAL CO2 (ETCO2) SENSOR AND CONNECTED TO A 15 L/MIN OXYGEN SOURCE. FIC02 ELEVATION ISSUE: WHILE USING THE SUNMED MANUAL RESUSCITATOR, THE PATIENT'S FRACTION OF INSPIRED CO2 (FICO2) LEVELS INCREASED UNTIL THE CLINICAL TEAM PLACED THE PATIENT ON A VENTILATOR. THIS INCREASE BEGAN AT 10:24.20 (FIGURE 1) AND PEAKED AT 36 MMHG AT 10:25.43 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 10 AND 30 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO A VENTILATOR AT 10:26.51. THE ELEVATION IN FICO2 RESOLVED ONCE THE VENTILATOR WAS INITIATED (FIGURE 4). PRODUCT PROBLEM: SUSPICIONS ARISE THAT THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF THE ABNORMAL FIC02 ELEVATION. THE FIC02 INCREASE POSES A RISK OF HYPERCAPNIA, WHICH CAN SIGNIFICANTLY IMPACT THE PATIENT'S BODILY FUNCTIONS, PHYSICAL WELL-BEING, AND POTENTIALLY LEAD TO LIFE-THREATENING CONSEQUENCES. FURTHERMORE, THIS INCONSISTENCY RAISES CONCERNS REGARDING ADHERENCE TO PERFORMANCE SPECIFICATIONS AND USER EXPECTATIONS. PATIENT OUTCOME: THE PATIENTS OUTCOME IS UNKNOWN, AS CARE WAS HANDED OVER TO ANOTHER PROVIDER. REFER TO ADDITIONAL DOCUMENTS IN I2K.