inforMED
InjuryBTM

MANUAL RESUSCITATOR WITH MANOMETER

Received Dec 5, 2023 · Event occurred Jul 3, 2023

Report MW5148852 · MDR key 18274469

Device

Generic name

Ventilator, Emergency, Manual (resuscitator)

Model number

AF1100MB

Patient

41 YR · Male

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Decreased Level of Consciousness
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
  • Decreased Level of Consciousness

Narrative

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. REFER TO ADDITIONAL DOCUMENTS IN I2K.