MAUDE Adverse Event Report: SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8DCT
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, an audible leak coming from the patient tracheostomy was heard.The ventilator showed a low minute ventilation alarm notification.A volume of air was introduced to correct the leak.A few minutes later, an audible leak was noted again.Due to the multiple introductions of air through the device pilot balloon and the device not holding volume, it was assessed that there was a leak in the device.An emergency device change was performed due to constant introduction of air in the pilot cuff.No adverse reaction was noted to the patient.The patient was re-assessed as not distressed as noted vital signs were stable.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• MDR Report Key: 12548696
• Report Number: 2936999-2021-00970
• Device Sequence Number: 3322574
• Product Code: JOH
• UDI-Device Identifier: 20884522029022
• UDI-Public: 20884522029022
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/29/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2025
• Device Model Number: 8DCT
• Device Catalogue Number: 8DCT
• Device Lot Number: 21C1126JCX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1