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

Device Problems Leak/Splash (1354); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Tachycardia (2095); Increased Respiratory Rate (2486)

Event Date 06/01/2022

Event Type  Injury  

Event Description

Patient is a resident of (b)(6) (sub-acute unit).Patient is awake and alert, and is ventilator and trach dependent.Patient has a flexible shiley 8 tracheostomy tube, ventilator settings ac/vc rr 14, vt 450, peep +5, fio2 28%.Patient had a routine tracheostomy tube change performed on (b)(6) 2022, with no complications.On (b)(6) 2022 approximately 2345, (b)(6), rcp responded to ventilator alarm.Upon entering the room, rcp noted ventilator alarm showing low vt and low ve.Rcp attempted to troubleshoot alarm, by checking for leak in circuit, repositioning patient and tracheostomy tube.Rcp attempted to re-inflate pilot balloon with no improvement, large leak was still noted.(b)(6), rcp performed emergency tracheostomy tube change and inserted a new shiley 8cn85h tracheostomy tube.Pt was placed back on mechanical ventilator with same settings.Low vt and low ve alarm no longer noted.Vital signs were checked and patient remains in stable condition.Spo2 99%, hr 120, rr 24.Lead rt and charge rn made aware.Product was kept for investigation.Upon investigation, s8cn85h tracheostomy tube was submerged into water and pilot balloon was inflated with a 10 cc syringe.Air bubbles were noted on cuff and cuff was unable to maintain volume.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: 14632455
• MDR Text Key: 293660593
• Report Number: MW5110176
• 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: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Native Hawaiian Or Other Pacific Islander