MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; CONTINUOS VENTILATOR

Model Number VIVO 50

Device Problem Failure to Run on Battery (1466)

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

Event Date 03/03/2020

Event Type  malfunction  

Event Description

Per the reporter: the treatment was terminated when running on the internal battery.It has been confirmed that there was no patient injured in this event.

• Brand Name: BREAS VIVO 50
• Type of Device: CONTINUOS VENTILATOR
• 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: elisabeth carlsson ; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 11511259
• MDR Text Key: 242395294
• Report Number: 9617566-2020-00001
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 07321822150005
• UDI-Public: 7321822150005
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K123144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VIVO 50
• Device Catalogue Number: 215000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1