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

Model Number 2002-000

Device Problem Noise, Audible (3273)

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

Event Date 12/17/2018

Event Type  malfunction  

Event Description

Patient had coronary artery bypass graft (cabg).When patient arrived to room and while setting up the chest tube suctions, a loud unknown noise was coming from atriums.Troubleshooting was done, unable to find the source.Both atriums were changed-noise was resolved.

Event Description

Patient had coronary artery bypass graft (cabg).When patient arrived to room and while setting up the chest tube suctions, a loud unknown noise was coming from atriums.Troubleshooting was done, unable to find the source.Both atriums were changed-noise was resolved.

• Brand Name: OCEAN
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8451480
• MDR Text Key: 139824288
• Report Number: 8451480
• 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
• Type of Report: Initial,Followup
• 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: Other
• Device Model Number: 2002-000
• 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
• Patient Sequence Number: 1
• Patient Age: 29200 DA