MAUDE Adverse Event Report: MEDTRONIC FABRICATION S.A.S. SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	8LPC-S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	07/25/2019
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, the device cuff had inflation/deflation issue.After decanulation of the tracheostomy tube, the cuff maintained its pressure for 3 days indicating it was not leaking.It was already removed from patient and there had been a run of the cuff's leaking lately.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device cuff had inflation/deflation issue.It was reported that after decannulation of the tracheostomy tube, the cuff maintained its pressure for 3 days indicating it was not leaking.It was already removed from patient and there had been a run of the cuff's leaking lately.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.A visual inspection was performed and it was observed all the components are assembled properly.An inflation/deflation test was performed and it was observed the cuff inflated and held the air, and no leaks were observed, additionally the cuff, inflation line and valve were submerged into a container filled with water and no leaks were observed.Therefore, no failure mode was observed in the received sample since met with the product specifications and no corrective actions are required.No new formal investigation is required, the event will be included in trending and monitoring.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device cuff had inflation/deflation issue.It was reported that after decannulation of the tracheostomy tube, the cuff maintained its pressure for 3 days indicating it was not leaking.The customer indicated it was already removed from patient and there had been a run of the cuff's leaking lately.The patient was decannulated.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MEDTRONIC FABRICATION S.A.S.; 103 route d anor; fourmies nord 59610 ; FR 59610
• MDR Report Key: 8910292
• Report Number: 9611350-2019-00012
• Device Sequence Number: 10814373
• Product Code: JOH
• UDI-Device Identifier: 20884522031988
• UDI-Public: 20884522031988
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8LPC-S
• Device Catalogue Number: 8LPC-S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 08/22/2019; 09/10/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/03/2019; 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention