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

Model Number 353/19004

Device Problem Material Integrity Problem (2978)

Patient Problem Respiratory Distress (2045)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, patient was in bed, in acute respiratory distress (polypnea, inspiratory and expiratory circulation).Tra cheotomized patient, ventilated with artificial nose under oxygen.The cause of distress was the artificial nose filled with pulmonary secretions, preventing adequate respiratory.They have solved the problem by opening of the lid of the artificial nose.

• 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: avi kluger ; 5920 longbow drive; boulder, CT 80301 ; 3035306582
• MDR Report Key: 8620824
• MDR Text Key: 145500777
• Report Number: 2936999-2019-00356
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K941535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2019

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/17/2019
• 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