MAUDE Adverse Event Report: KENDALL GAMMATRON, THAILAND MALLINCKRODT; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number 107-70

Device Problem Gas/Air Leak (2946)

Patient Problems Hypoventilation (1916); Unintended Extubation (4564)

Event Type  malfunction  

Event Description

According to the reporter, intra-operatively, there was a leak in the balloon after 30 minutes of the procedure, which did not sustain the pressure, so the patient had an alternate airway inserted.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

New information has been received, and reassessment of the complaint found that it is no longer a reportable event.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.The product is not marketed nor is similar to a product marketed in the region governed by this regulation.The product is not a ¿single entity¿ or ¿co-packaged¿ combination product.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MALLINCKRODT
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): KENDALL GAMMATRON, THAILAND; nakhon chai si district; nakhon pathom ; TH
• Manufacturer (Section G): KENDALL GAMMATRON, THAILAND; nakhon chai si district; nakhon pathom ; TH
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19094036
• MDR Text Key: 340240549
• Report Number: 8040459-2024-00026
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2024

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: 107-70
• Device Catalogue Number: 107-70
• Device Lot Number: 2324814FEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/11/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/03/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1