MAUDE Adverse Event Report: NULL; TRACHEOSTOMY TUBE

Model Number 100/150/065

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported the cuff didn't remain inflated.This incident occurred after use on the patient in the recovery room at the time of extubation.No health consequence for the patient.

• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section G): NULL
• MDR Report Key: 12820454
• MDR Text Key: 280829925
• Report Number: 3012307300-2021-11223
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2021

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
• Device Operator: Health Professional
• Device Model Number: 100/150/065
• Device Catalogue Number: 100/150/065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1