MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 65; CONTINUOUS VENTILATOR

Model Number BREAS VIVO 65

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  Death  

Manufacturer Narrative

Breas medical was made aware of this event via the distributor.It was not reported directly to breas as a complaint.There is no allegation of device malfunction.

Event Description

Patient passed, was held at coroner's office until january.Mother was afraid that nurse had erased alarm data so she sent it to the county coroner's office, while at the coroner's office i was able to show the coroner that the vent was alarming appropriately.Mother feels that it was a nursing error and that patient had been decannulated.

Manufacturer Narrative

Analysis of log files is not possible.The log files pertaining to the adverse event had been erased prior to return of the device to breas and it is therefore not possible to analyze any log files for this event.Functional test of the returned device was performed.All tests passed.The conclusion of the investigation is that the device performs as intended and according to specification, and no correlation between the reported event and any device malfunction can be established.

• Brand Name: BREAS VIVO 65
• Type of Device: CONTINUOUS VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; företagsvägen 1; mölnlycke, 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; företagsvägen 1; mölnlycke, 43533 ; SW 43533
• Manufacturer Contact: carina finnäs ; mölnlycke, 43533 ; SW 43533
• MDR Report Key: 15586430
• MDR Text Key: 301550443
• Report Number: 9617566-2022-00009
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BREAS VIVO 65
• Device Catalogue Number: 225000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2022
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death