MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS DRY SUCTION WATER SEAL CHEST DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3600-100

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.Device not returned.

Event Description

Hospital reported the oasis drain appears to have more air leaks compared to a different brand.

Manufacturer Narrative

The complaint alleges that the atrium medical corporation oasis chest drainage system has more leaks than competitor¿s drainage systems.There was no data to support this allegation.All atrium medical chest drainage systems are 100% pressure tested prior to final packaging to ensure the integrity of the product functionality.The product was designed to make the possibility of an air leak easier for the clinician to see as the air leak chamber has a large viewing window with the water that is in the air leak chamber tinted blue.Based on the results of the investigation the oasis chest drain performs properly for its intended use and there is no evidence to conclude that the device in this instance was faulty.

Event Description

N/a.

• Brand Name: OASIS DRY SUCTION WATER SEAL CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9310191
• MDR Text Key: 173757320
• Report Number: 3011175548-2019-01160
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862110012
• UDI-Public: 00650862110012
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1