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	Extubate (2402); No Information (3190)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
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.There was no reported patient outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 indicated that 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: 8861388
• Report Number: 9611350-2019-00007
• Device Sequence Number: 2087593
• Product Code: JOH
• UDI-Device Identifier: 20884522031957
• UDI-Public: 20884522031957
• 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?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/06/2019; 09/11/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/28/2019; 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
• Patient Age: 35 YR