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

Device Problems Air Leak (1008); Break (1069)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study outpatient management of air leaks is safe and effective.[(b)(4)].

Event Description

Received an article titled "outpatient air leak management after lobectomy: a cms cost analysis".The purpose of the article was to evaluate the safety and cost efficiency of a protocol for outpatient management of air leaks with a portable drainage system (pds).Per the article five device malfunctions related to broken chambers.

• 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: 7535870
• MDR Text Key: 109104947
• Report Number: 3011175548-2018-00500
• 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: Physician
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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