MAUDE Adverse Event Report: KENDALL GAMMATRON, THAILAND CURITY; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	9480E
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	07/06/2020
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 procedure, the cuff deflated and there was a loss of mechanical breathing due to defected cuff.It happened three times with the same patient.It was indicated that they changed the tube three times.

• Brand Name: CURITY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): KENDALL GAMMATRON, THAILAND; nakhon chai si district; nakhon pathom ; TH
• MDR Report Key: 10311013
• Report Number: 8040459-2020-00041
• Device Sequence Number: 2261167
• Product Code: BTR
• UDI-Device Identifier: 20705031235233
• UDI-Public: 20705031235233
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: K892432
• 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
• Report Date (Section B): 07/22/2020

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: 9480E
• Device Catalogue Number: 9480E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/22/2020
• 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