SUNMED LLC

Description of Event or Problem

PATIENT PRESENTATION: AN SEMI-RESPONSIVE/CONFUSED PATIENT, FROM A HIGH SPEED ATV ACCIDENT WITHOUT A HELMET, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 9, 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) MANUAL RESUSCITATOR WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 10 CMH2O, IN-LINE END-TIDAL CO2 (ETCO2) SENSOR AND CONNECTED TO A 15 UMIN 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 14:16.08 (FIGURE 1) AND PEAKED AT 53 MMHG AT 14:27.25 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 20 AND 50 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO A VENTILATOR AT 14:31.30. 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.

Additional Manufacturer Narrative

THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF ABNORMAL FICO2 ELEVATION. THIS IS THE ISSUE THAT WAS REFERRED TO IN THE FIELD NOTIFICATION INITIATED ON OCT 11, 2023. IN ADDITION, THE FDA MEDWATCH REPORT WAS RECEIVED. THE COMPLAINT OF "THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF ABNORMAL FICO2 ELEVATION" REGARDING PART AF1100MB WAS CONFIRMED TO BE ASSOCIATED WITH NCMR-02506. A RESOLUTION LETTER WAS NOT REQUESTED BY THE CUSTOMER.

Description of Event or Problem

PATIENT PRESENTATION: AN SEMI-RESPONSIVE/CONFUSED PATIENT, FROM A HIGH SPEED ATV ACCIDENT WITHOUT A HELMET, WAS ASSESSED WITH A GLASGOW COMA SCALE (GCS) SCORE OF 9, 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) MANUAL RESUSCITATOR WITH A MANOMETER, POSITIVE END-EXPIRATORY PRESSURE (PEEP) VALVE SET AT 10 CMH2O, IN-LINE END-TIDAL CO2 (ETCO2) SENSOR AND CONNECTED TO A 15 UMIN 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 14:16.08 (FIGURE 1) AND PEAKED AT 53 MMHG AT 14:27.25 (FIGURE 2). FICO2 LEVELS FLUCTUATED BETWEEN 20 AND 50 MMHG (FIGURE 3) UNTIL THE PATIENT WAS TRANSITIONED TO A VENTILATOR AT 14:31.30. 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.

Additional Manufacturer Narrative

THE MANUAL RESUSCITATOR MAY BE THE SOURCE OF ABNORMAL FICO2 ELEVATION. THIS IS THE ISSUE THAT WAS REFERRED TO IN THE FIELD NOTIFICATION INITIATED ON OCT 11, 2023. IN ADDITION, THE FDA MEDWATCH REPORT WAS RECEIVED.