MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 40; CONTINOUS VENTILATOR

Model Number	VIVO40
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/18/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
This report is submitted retrospectively because it is not visible in maude data base.The manufacturer was informed about the incident one year and five months after the incident occured.First report was submitted 13-02-2019.
Event or Problem Description
Patient with als has had several bipap ventilators since (b)(6) 2015.On the evening (b)(6) 2017 the patient notified the homecare provider.When they arrived the patient was deceased.The hospital's investigation showed that bipap (vivo 40) was functioning but the battery was discharged.It was also noted that the power cable was not fully inserted into the device.The incident resulted in an lexmaria notification and landstingent i varmland conducted an investigation.(dated (b)(6) 2018, (b)(4)).The log files were investigated the device gave audible and visual alarm as designed.The root cause could not be established.Possible scenarios according to the customers investigation is: use error or product malfunction.Breas was notified of the incident (b)(6) 2019, more than a year after the incident.Breas has not had any access to the device or log files and no investigation has been performed.Information in the investigations done by the customer and landstingent i varmland indicate the device acted as designed.

• Brand Name: BREAS VIVO 40
• Common Device Name: CONTINOUS VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 12518791
• Report Number: 9617566-2019-00007
• Device Sequence Number: 11779261
• Product Code: NOU
• UDI-Device Identifier: 07321822010002
• UDI-Public: 07321822010002
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K053607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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: No Information
• Device Model Number: VIVO40
• Device Catalogue Number: 201000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death