MAUDE Adverse Event Report: SUNMED HOLDINGS, LLC CURAPLEX MANUAL RESUSCITATOR WITH MANOMETER; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 2442-BVMPSA

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/02/2023

Event Type  Injury  

Event Description

Patient presentation: an unresponsive patient, suffering from a four-story fall, was assessed with a glasgow coma scale (gcs) score of 5, indicative of severe consciousness impairment.Medical interventions: rapid sequence intubation (rsi) was performed to establish airway patency.The endotracheal tube (ett) was ventilated with a small adult curaplex (2422-bvmpsa) manual resuscitator with a manometer, positive end-expiratory pressure (peep) valve set at 15 cmh2o, in-line end-tidal co2 (etc02) sensor and connected to a 15 l/min oxygen source.Fic02 elevation issue: while using the curaplex 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 15:56.24 (figure 1) and peaked at 35 mmhg at 15:58.03 (figure 2).Fico2 levels fluctuated between 20 and 35 mmhg (figure 3) until the patient was transitioned to an ambu manual resuscitator at 15:58.46.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.

• Brand Name: CURAPLEX MANUAL RESUSCITATOR WITH MANOMETER
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SUNMED HOLDINGS, LLC
• MDR Report Key: 18274462
• MDR Text Key: 329994192
• Report Number: MW5148851
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2442-BVMPSA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening; Disability
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic