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

Model Number	16100
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon the completion of the investigation into this event.
Event or Problem Description
Report received stated that the nurse found that a pneumostat was leaking from the white chamber.
Additional Manufacturer Narrative
Analysis - the details provided indicate that the pneumostat drain was leaking and upon further investigation discovered that the drain was not being held in the upright position as detailed in the instructions for use.The instructions for you clear precaution the user to maintain the pneumostat in the upright position.An in service was conducted to show the proper operation of the pneumostat based on the instructions for use.The ifu in the precautions specifies the following: precaution: line item 5 chest drain valve must be kept in its upright position.Line item 6.Patient tube connection, air leak well, and needleless luer-lock port should be checked regularly to confirm proper operation¿.Summary/conclusion - based on the results of the investigation the leak in the pneumostat was caused by user error.The drain, as mentioned in the complaint details, was not kept in the upright position as described in the instructions for use.Based on the details of the complaint the drain was functioning properly.

• Brand Name: PNEUMOSTAT
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9777727
• Report Number: 3011175548-2020-00362
• Device Sequence Number: 11617719
• Product Code: KDQ
• UDI-Device Identifier: 00650862161007
• UDI-Public: 00650862161007
• Combination Product (Y/N): N
• Initial Reporter State: NV
• PMA/510(K) Number: K984496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16100
• Device Catalogue Number: 16100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1