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

Model Number	10CN10H
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Codes	Hypoventilation (1916); Unintended Extubation (4564)
Date of Event	03/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, the patient had a recent emergency tracheostomy change due to malfunction.Patient was noted with no return tidal volumes on the ventilator, rcp attempted to re-inflate the pilot balloon but was unsuccessful.Emergency tube replacement was performed.The patient was changed from a size 10 tube to a xlt8.Tracheostomy tube was kept and was submerged in the water.The pilot balloon had a noticeable air bubbles.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 14437478
• Report Number: 2936999-2022-00431
• Device Sequence Number: 5634864
• Product Code: JOH
• UDI-Device Identifier: 10884521172371
• UDI-Public: 10884521172371
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/18/2022

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 Model Number: 10CN10H
• Device Catalogue Number: 10CN10H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2022
• Initial Report FDA Received Date: 05/19/2022
• 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
• Patient Sex: Unknown