MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	4CN65H
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	12/11/2017
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, during use of the device, it had an issue with cuff inflation/deflation.The cuff was inflated to 23 cmh2o and was reduced to 5-10 cmh20.The tube was removed and replaced.There was no patient 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, during use of the device, it had an issue with cuff inflation/deflation.The cuff was inflated to 23 cmh2o and was reduced to 5-10 cmh20.It was reported that tube was removed and replaced.

• Brand Name: SHILEY
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 7160455
• Report Number: 2936999-2018-00001
• Device Sequence Number: 16518474
• Product Code: JOH
• UDI-Device Identifier: 20884521176307
• UDI-Public: 20884521176307
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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 Expiration Date: 07/12/2021
• Device Model Number: 4CN65H
• Device Catalogue Number: 4CN65H
• Device Lot Number: 16G0340JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 03/07/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 03/07/2018
• 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: Other; Required Intervention