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

Model Number	VIVO 50
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CONTINUOS VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 11511259
• Report Number: 9617566-2020-00001
• Device Sequence Number: 3622322
• Product Code: NOU
• UDI-Device Identifier: 07321822150005
• UDI-Public: 7321822150005
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K123144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection,Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VIVO 50
• Device Catalogue Number: 215000
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1