MAUDE Adverse Event Report: COOK INCORPORATED MELKER; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	G32193
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Balloon in cricothyrotomy kit would not inflate.

• Brand Name: MELKER
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10343585
• Report Number: 10343585
• Device Sequence Number: 11602709
• Product Code: JOH
• UDI-Device Identifier: 00827002321939
• UDI-Public: (01)00827002321939
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/24/2020
• Report Date (Section F): 07/24/2020

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: No Information
• Device Model Number: G32193
• Device Catalogue Number: C-TCCSB-500-UNI
• Device Lot Number: 9601065
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/24/2020