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

Model Number VIVO 65

Device Problems Disconnection (1171); Display or Visual Feedback Problem (1184)

Patient Problem Insufficient Information (4580)

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

Note: this report is submitted retrospectively because the original report is not visible in maude database.

Event 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
• Type of Device: 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
• MDR Text Key: 294190157
• Report Number: 9617566-2019-00002
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 07321822245169
• UDI-Public: 07321822245169
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K160481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other