MAUDE Adverse Event Report: BREAS MEDICAL AB VIVO 45LS; VENTILATOR

Model Number	230000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Breas ventilator being used in patient home.Therapist reported the ventilator was not producing a disconnection alarm when they visibly noticed that the patient was disconnected from the ventilator.When therapist arrived at the home she disconnected the patient from the vent and found the vent did not alarm.
Additional Manufacturer Narrative
Breas contacted the reporter of this event to request the serial number (which was not provided in the initial report) and the device for investigation.The reporter responded on (b)(6) 2025: 'no need to.The breas team knew about the three that we had concerns with.The one was sent back.The other two we could not duplicate the issue.As of right now we have had no other issues.Our team at home healthcare is working with your team with clinical education and any technical support needed.' the reporter did not provide the serial number and advised that no further investigation was required.Breas will close this issue at this time.

• Brand Name: VIVO 45LS
• Common Device Name: VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlylcke, vastra gotland 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotland 43533 ; SW 43533
• Manufacturer Contact: ramsey lancaster ; foretagsvagen 1; molnlycke, vastra gotland 43533 ; SW 43533
• MDR Report Key: 23292707
• Report Number: 9617566-2025-00019
• Device Sequence Number: 4824269
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: 010732182230000411240629
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K193586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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
• Device Model Number: 230000
• Device Catalogue Number: 230016
• 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: 09/11/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic