MAUDE Adverse Event Report: ATRIUM MEDICAL EXPRESS MINI MOBILE DRY SEAL DRAIN; BOTTLE, COLLECTION, VACUUM

Device Problem Air Leak (1008)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study, the use of the star shows decreased post-operative prolonged air leaks.

Event Description

Received an article titled "standardized approach to prolonged air leak reduction after pulmonary resection." the purpose of the article was for the standardized approach to air leak reduction (star) after lung resection was developed and studied.Per the article, deaths occurred during the study period.

• Brand Name: EXPRESS MINI MOBILE DRY SEAL DRAIN
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7538524
• MDR Text Key: 109096832
• Report Number: 3011175548-2018-00515
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• PMA/PMN Number: K984496
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Nursing Assistant
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2018
• 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 Outcome(s): Death