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

Catalog Number 2012-320

Device Problem Suction Problem (2170)

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

Event Date 09/17/2015

Event Type  malfunction  

Event Description

A pediatric atrium water-seal chest drain, when on low suction, had bubbles appearing at the 10cm h2o area rather that from the bottom of the water seal (20cm h2o).The implication is atrium not consistently providing the full suction of 20cm h2o.

• Brand Name: OCEAN
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM; 5 wentworth drive; hudson NH 03051
• MDR Report Key: 5343179
• MDR Text Key: 35014998
• Report Number: 5343179
• Device Sequence Number: 1
• Product Code: KDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 2012-320
• Device Lot Number: 226726
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/06/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1