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

Model Number	3600-100
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: a2, b4, g1, g2, g3, g6, h2, h6, h11 the complaint reported that an audible leak was heard during use of an oasis drain.The reporter indicated that the same issue occurred with a second drain from the same lot, which was reported separately.The product associated with this complaint was not returned for evaluation.However, testing of the related returned unit identified no damage, and the product functioned as intended.No audible leak or abnormal sound could be reproduced during evaluation.The complaint did not specify the source of the reported sound.Potential sources external to the device, such as the patient line connection or wall suction equipment, could not be evaluated and may have contributed to the reported observation.A device history record review found no manufacturing non conformances, and review of the instructions for use confirmed that adequate setup and operating instructions are provided.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.Based on the available information, neither the reported audible leak nor a product-related non conformance could be confirmed.No evidence of a manufacturing or product deficiency was identified, and the root cause could not be determined.

• 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: 50054369
• Report Number: 3011175548-2026-000008
• Device Sequence Number: 18521134
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012(10)522738(17)280810
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/18/2026

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: 522738
• 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: 07/10/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 239 LB