MAUDE Adverse Event Report: BREAS MEDICAL AB VIVI 65; VENTILATOR CONTINOUS FACILITY USE

Model Number	VIVO65
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/10/2022
Type of Reportable Event	Death
Event or Problem Description
Breas medical inc.Has determined that an event occurred on (b)(6) 2022 involving a vivo 65 ventilator.This event was not reported by the site.The dme has advised that a child died while connected to a vivo 65 device and in a car travelling.
Additional Manufacturer Narrative
Breas medical inc.Was not notified initially when the adverse event occurred.The information was obtained through hearsay and in the initial investigation, breas medical inc.Was unable to gain any information about the event and/ or verify that the event actually happened.In a later investigation, breas medical inc.Made contact with the dme in possession of the ventilator and was able to get details about the event as indicated in this report.The device has not been returned to breas medical inc.At this time, but we did receive the log files for the device from the dme and our engineering team was able to analyze those files.The conclusion from the analysis is that the device performed according to specification.On the date of the event, there were alarms related to pressure and volume limits exceeded.There were no power failures or other stops in treatment throughout the day on (b)(6), with the exception of one standby event at 23:59:54 on (b)(6) which indicates that treatment was manually stopped on the device.The investigation result supports the conclusion that the device did not cause or contribute to the incident.

• Brand Name: VIVI 65
• Common Device Name: VENTILATOR CONTINOUS FACILITY USE
• 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: 15189632
• Report Number: 9617566-2022-00006
• Device Sequence Number: 12163344
• Product Code: CBK
• UDI-Device Identifier: 07321822245169
• UDI-Public: 07321822245169
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K160481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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
• Operator of Device: Lay User/Patient
• Device Model Number: VIVO65
• Device Catalogue Number: 224000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown