MAUDE Adverse Event Report: MEDTRONIC / COVIDIEN SHILEY FLEX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Device Problem Gas/Air Leak (2946)

Patient Problems Cardiac Arrest (1762); Hypoxia (1918); Diminished Pulse Pressure (2606)

Event Date 08/13/2021

Event Type  Death  

Event Description

Patient received a percutaneous trach 6 cuff shiley ((b)(4)) on (b)(6) 2021.On (b)(6) 2021, patient unable to be ventilated developed subcutaneous air in face and neck.New 8 shiley trach placed, balloon did not hold, significant air leak.New 8 shiley placed.Inflation held.Noted hypoxia and pea arrest.Patient expired.Fda safety report id # (b)(4).

• Brand Name: SHILEY FLEX
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MEDTRONIC / COVIDIEN
• MDR Report Key: 12632485
• MDR Text Key: 276650333
• Report Number: MW5104578
• Device Sequence Number: 1
• Product Code: BTO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/08/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 76 YR
• Patient Weight: 103