MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)

Model Number 353/19004

Device Problem Obstruction of Flow (2423)

Patient Problems Dyspnea (1816); Hypoxia (1918)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, the patient was suffocated.The connection was unplugged and the patient got better.The device was connected again and the patient strongly resisted and had dyspnea, so it was immediately removed.It had been verified that after the device was connected to oxygen, there was no gas discharged from the gas-cut connection end and it was blocked.The device was replaced.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, the patient was suffocated.The connection was unplugged and the patient got better.The device was connected again and the patient strongly resisted and had dyspnea, so it was immediately removed.It had been verified that after the device was connected to oxygen, there was no gas discharged from the gas-cut connection end and it was blocked.The device was replaced.There were no other medical interventions done related to asphyxia and dyspnea aside from oxygen inhalation.

• Brand Name: DAR
• Type of Device: CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer (Section G): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view,mn, CO 55112 ; 7635265677
• MDR Report Key: 15113131
• MDR Text Key: 304332714
• Report Number: 2936999-2022-00688
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K941535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

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
• Device Operator: Health Professional
• Device Model Number: 353/19004
• Device Catalogue Number: 353/19004
• Device Lot Number: 21E0390FAX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 08/23/2022
• Supplement Dates FDA Received: 09/07/2022
• Date Device Manufactured: 06/27/2021
• 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
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 72 KG