MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; CONTINUOUS VENTILATOR, PRODUCT CODE: NOU

Model Number VIVO 50

Device Problems Failure to Run on Battery (1466); Unexpected Shutdown (4019)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

This report is submitted retrospectively because the original report is not visible in maude database.

Event Description

It was reported by the customer that the device did not switch over to the internal battery when the external battery was changed.In doing so the device shut down.This report is submitted retrospectively because the original report is not visible in maude database.

• Brand Name: BREAS VIVO 50
• 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: 14452021
• MDR Text Key: 294567640
• Report Number: 9617566-2019-00004
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00732182215005
• UDI-Public: 0732182215005
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K123144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/22/2019

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 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other