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

Model Number AF1100MB

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

Event Date 07/03/2023

Event Type  Injury  

Event Description

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.

• Brand Name: MANUAL RESUSCITATOR WITH MANOMETER
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): SUNMED HOLDINGS, LLC
• MDR Report Key: 18274469
• MDR Text Key: 329938377
• Report Number: MW5148852
• 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

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AF1100MB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Life Threatening; Other
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic