MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. EXPRESS DRY SEAL CHEST DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 4000-100

Device Problem Insufficient Information (3190)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

Customer reported that they noticed an increase in recurrent pneumothorax and they believe it may be attributed to the chest drain.There were no specific pt details provided or specific prod lot numbers.

Manufacturer Narrative

We are awaiting add'l details regarding the incident and will submit a f/u report once the eval is completed.Related mfr: 1219977-2015-00070.

• Brand Name: EXPRESS DRY SEAL CHEST DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr coord ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 4584961
• MDR Text Key: 5336916
• Report Number: 1219977-2015-00068
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4000-100
• Device Catalogue Number: 4000-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention