MAUDE Adverse Event Report: Atrium Medical Corporation OASIS; Bottle, Collection, Vacuum

Model Number	3600-100
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported that while using the oasis drain, the device was accidentally knocked over.The user denied experiencing shortness of breath, increased work of breathing, or chest pain.The user also stated that the drainage had moved to "the other side of the drain."following review of the provided photograph by the esp team, brown fluid was observed in the water seal/air leak monitor window and water seal column, with the fluid level exceeding the intended 2 cm water seal level.No patient harm or adverse event was reported.
Additional Manufacturer Narrative
Due to character limit in e1.Full event site name: (b)(6) health ctr.A supplemental report will be submitted upon completion of our investigation.

• Brand Name: OASIS
• Common Device Name: Bottle, Collection, Vacuum
• Manufacturer (Section D): Atrium Medical Corporation; 40 continental blvd; merrimack NH
• Manufacturer (Section G): Atrium Medical Corporation; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 50867173
• Report Number: 3011175548-2026-000012
• Device Sequence Number: 21177082
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043140
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: 3600-100
• Device Catalogue Number: 3600-100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: Unknown
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 235 LB