MAUDE Adverse Event Report: GETINGE / ATRIUM MEDICAL CORPORATION ATRIUM OASIS DRY SUCTION WATER SEAL CHEST DRAIN 3600; APPARATUS, AUTOTRANSFUSION

Device Problem Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

While the chest tube is connected to wall suction, constant bubbling is noted in the water seal chamber indicating an air leak when there is no actual air leak present.When the chest tube is removed from suction (placed to waterseal), the constant bubbling subsides and normal tidaling can be observed indicating there is not an air leak.This was observed on an atrium that was newly changed.The concern is if there is an issue with the internal pressure regulation of the atrium itself and with t he ball being too low in the waterseal chamber/not floating properly.

• Brand Name: ATRIUM OASIS DRY SUCTION WATER SEAL CHEST DRAIN 3600
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): GETINGE / ATRIUM MEDICAL CORPORATION
• MDR Report Key: 16468460
• MDR Text Key: 310723307
• Report Number: MW5115379
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Sex: Male