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

Model Number 353/19004

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Dyspnea (1816)

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device was not having any visible damage, but the patients complained about breathlessness.There were no complications as they got connected to a new device immediately.

Manufacturer Narrative

Evaluation summary: the reported device used was not retained by the customer and therefor not available for evaluation.Eleven boxes containing two-hun dred-seventy-five unused samples still in their original sealed packaging were received.A flow resistance test was performed on the samples to determine pressure resistance in the filters.All samples were found to be within specification limits.The investigation found all devices functioned as intended.Information has been added to the database and trends will continue to be monitored.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.

• 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
• MDR Report Key: 9616538
• MDR Text Key: 175899784
• Report Number: 2936999-2020-00057
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• PMA/PMN Number: K941535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• 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: 19K1050FAX
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 01/16/2020
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1