MAUDE Adverse Event Report: COVIDIEN MEDTRONIC SHILEY FLEXIBLE TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

Patient Problem Convulsion/Seizure (4406)

Event Date 03/16/2022

Event Type  Injury  

Event Description

Patient initially admitted to (b)(6) on (b)(6) 2022 from sub acute due to witnessed seizures.Patient is trach dependent on cool aerosol, with a history of paralysis of vocal cords, htn, gerd, ascites, and cirrhosis per patient's medical record.On (b)(6) 2022, trach was replaced by (b)(6) and patient was placed on mechanical ventilator due to continuous episodes of seizures.On (b)(6) 2022, patient was trailed on cool aerosol collar.Patient was having episodes of active seizures on (b)(6) 2022, and was placed back on mechanical ventilator by (b)(6) orders.After placing patient on mechanical vent, rcp inflated patient's cuff but noticed the cuff was not maintaining air and.(b)(6) was called to bedside and a new shiley 6 flexible trach (6cn75h) was inserted.Patient was placed on mechanical ventilator with no signs of respiratory distress noted.Investigation of the tracheostomy tube was performed, trach was submerged into water and cuff was inflated.Bubbles were noticeably present.Will report incident to medwatch link.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC SHILEY FLEXIBLE TRACHEOSTOMY
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 13839968
• MDR Text Key: 287664526
• Report Number: MW5108340
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 53 KG
• Patient Ethnicity: Hispanic