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

Model Number	3600-100
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while poring water in the oasis drain it was directed to the wrong spot.There was no harm or adverse event reported.
Additional Manufacturer Narrative
Upon completion of the investigation into this event a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional field: b5, h6 corrected field: a, b6, b7, d10, e1- event site name, h6-(component, health effect ¿ impact codes) this complaint reports that while an oasis drain (p/n 3600-100, l/n 520674) was being set up, water that was poured in was "directed to the wrong spot." a picture was received from the customer which did not show the area of concern on the drain, but rather shows a sticky note that states the water was being diverted in "e spot." chamber e on the drain is the bellows chamber, which does not have a pathway to the suction nozzle for water to pass through.The drain was never attached to a patient.The device was returned for evaluation.A small amount of water could be seen in chamber e.The ink on the drain cover was removed so the internal chambers and welds could be seen more easily.No faulty/broken welds were identified and no pathway from the suction nozzle to chamber e was present.Water was poured into the suction nozzle an flowed into the water seal chamber as intended.The pprv (positive pressure relief valve) is an opening next to the suction nozzle but is recessed slightly on the top of the drain.If a user were to squirt water into that valve with some force, it is possible for it to push the float ball down and allow water to run down into chamber e.Due to the lack of any other way for water to enter that chamber, it appears that in this case that is most likely what happened.The ifu instructs the user to pour water through the suction nozzle and the iconographic instructions on the back of the drain shows this step.A user following these instructions should have no difficulty pouring the water into the correct opening.A dhr review was completed and no anomalies during manufacturing were identified.A recurring lot number report was completed which found no other complaints involving this lot.There is no evidence identified to indicate that this complaint is related to manufacturing, materials, design or equipment.The ifu provides adequate instructions for the setup and use of the device, including where to add water.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.A complaint history review was completed which found no similar complaints.The complaint is confirmed.A device nonconformance is not confirmed.Device evaluation showed that water passed correctly from the suction nozzle down to the water seal chamber.The most likely cause of this complaint is that water was forced through the pprv on the top of the drain and ran down into the bellows chamber.The root cause of this complaint is user error due to improper setup.
Event or Problem Description
Additionally it was reported that there was no patient involvement.

• 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: 23836320
• Report Number: 3011175548-2025-000013
• Device Sequence Number: 5081078
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012(10)520674(17)280609
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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
• Device Lot Number: 520674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 117 KG