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 11/30/2018

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 terminated treatment while changing the external battery.A fault was displayed and an acoustic alarm occured that could not be turned off.After connecting the device to mains it took 5 minutes until the device could be restarted again.The internal battery was fully charged like shown in the display.Meanwhile the patient was ventilated manually.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: 14453352
• MDR Text Key: 294567650
• Report Number: 9617566-2019-00006
• 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: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2018
• 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