MAUDE Adverse Event Report: HAMILTON MEDICAL AG INTELLICUFF; CUFF, TRACHEAL TUBE, INFLATABLE

Device Problems Product Quality Problem (1506); Gas/Air Leak (2946); Human-Device Interface Problem (2949); Pressure Problem (3012)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Ventilator Dependent (2395)

Event Date 11/11/2021

Event Type  Injury  

Event Description

My name is (b)(6) and i am a general surgeon at (b)(6) and i wanted to reach out about a product used in our intensive care unit that several of my partners have experienced complications with.The product is the intellicuff(b)(6), which is used as a continuous monitoring and adjustment device for cuff pressures in tracheostomies.I am part of a team which performs tracheostomies in ventilator dependent patients, and we have seen an increase in respiratory failure and ventilator dependence due to our covid surge.Typically if a patient can't be weaned from the ventilator after 3-4 weeks, our team is consulted for tracheostomy placement.I believe i am personally aware of about ten incidents in which immediately after a tracheostomy, the patient required emergent intervention because of leaking from around the tracheostomy cuff leading to inadequate ventilation and oxygenation.Yesterday a patient of mine experienced a cardiac arrest several hours after i placed a tracheostomy, and i believe this was from a cuff leak leading to hypoxia.The common denominator in all of these events seems to be the use of the intellicuff by our respiratory therapy department.My belief is that the device keeps the cuff pressures too low, or doesn't adequately perform the adjustments it's manufactured to do.In our covid population, airway pressures are very high and usually a constant high cuff pressure is necessary to keep ventilated gases within the respiratory tree.I believe the intellicuff somehow isn't able to adapt to this high pressure environment, leading to leaking problems.Perhaps there is a user error component originating from our respiratory therapists, but even in this case, it may point to a device which is too complicated to use safely.Fda safety report id# (b)(4).

• Brand Name: INTELLICUFF
• Type of Device: CUFF, TRACHEAL TUBE, INFLATABLE
• Manufacturer (Section D): HAMILTON MEDICAL AG; reno NV
• MDR Report Key: 12828331
• MDR Text Key: 280946916
• Report Number: MW5105366
• Device Sequence Number: 5
• Product Code: BSK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2021
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: 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): Life Threatening
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White