MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 65; CONTINUOUS VENTILATOR, PRODUCT CODE: NOU

Model Number	VIVO 65
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: this report is submitted retrospectively because the original report is not visible in maude database.
Event or Problem Description
Summary of problem refers to the activation of the "disconnect alarm".It has been witnessed that under certain circumstances, the disconnect alarm fails to activate.This is of concern as it related to decannulation of an invasively ventilated patient.Note: this report is submitted retrospectively because the original report is not visible in maude database.

• Brand Name: BREAS VIVO 65
• Common Device Name: CONTINUOUS VENTILATOR, PRODUCT CODE: NOU
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer Contact: gabriel vasiliu ; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 14451061
• Report Number: 9617566-2019-00002
• Device Sequence Number: 17437033
• Product Code: NOU
• UDI-Device Identifier: 07321822245169
• UDI-Public: 07321822245169
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K160481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: VIVO 65
• Device Catalogue Number: 224000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown