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

Model Number	3600-100
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow-up report will be submitted upon completion of our investigation.
Event or Problem Description
Report received stated that during use when the patient took a breath the float ball on an oasis drain had no oscillation on or off wall suction.There was no harm or patient injury.It was recommended to the nurse to get a chest x-ray performed in order to assess the patient¿s pneumothorax and report the findings to the physician.
Additional Manufacturer Narrative
Additional information: d9, h6.Getinge received a call from a nurse who was aiding in the treatment of a patient with an oasis (p/n 3600-100, l/n unknown) chest drain.They reported that there had been no harm to the patient, but wanted to know why the float ball would not be oscillating with the patient's breathing on or off suction.The getinge representative explained possible reasons for this to occur and encouraged the nurse to have an x-ray taken to review the status of the patient's pneumothorax.No pictures or lot number were provided and the device was not returned for evaluation.The float ball is located in the water seal column and aids the user in reading the internal pressure of the drain.In a closed system, the water level in the column rises and falls with changes in the patient's thoracic pressure, such as would occur during breathing.This is called tidaling and in that circumstance the float ball would rise and fall with the water.The water and float ball could remain stagnant if there is no significant change in pressure occurring.This can be caused by a leak somewhere in the system, most commonly an insecure connection or a pneumothorax in the patient.In this case it is known that the patient was being treated for a pneumothorax.Because this complaint is most likely caused by user error due to a lack of understanding of the drain, it is confirmed.A device nonconformance is not confirmed.A dhr review could not be completed because no lot number was provided.The ifu provides adequate instructions for setup and use of the device.It explains that the height of the water in the water seal chamber is indicative of the patient pressure, so it should be understood that changes in the height indicate a change in pressure and vice versa.Complaint trending found that the actual occurrence level did not exceed the anticipated occurrence level.No excursions were identified.A complaint history review was completed which found no similar complaints to this one.A recurring lot number report could not be completed because no lot number was provided.This complaint describes expected behavior of the drain and does not allege a device malfunction.The lack of tidaling in the water seal column can be caused by pneumothorax which the patient was being treated for.The complaint was a request for information on interpreting the drain.The ifu provides the information necessary to prevent this complaint.The root cause of this complaint is user error.

• 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: 22065354
• Report Number: 3011175548-2025-000004
• Device Sequence Number: 7634019
• Product Code: KDQ
• UDI-Device Identifier: 00650862110012
• UDI-Public: (01)00650862110012
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2025

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 06/26/2025
• 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
• Patient Sex: Unknown