MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OCEAN; BOTTLE, COLLECTION, VACUUM

Model Number 2002-000

Device Problems Overfill (2404); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  malfunction  

Event Description

Patient arrived from operating room (or) post coronary artery bypass graft (cabg) via operating room (or) team.While attempting to connect the chest tubes to suction, a different sound was heard from the atrium.When the atrium was checked, water on the air leak side was overfilled.This resulted in atrium not working properly.New atrium set up and changed.

• Brand Name: OCEAN
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8451442
• MDR Text Key: 139824420
• Report Number: 8451442
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2002-000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA