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 01/01/2022

Event Type  Death  

Event Description

(b)(6), from thrive skilled pediatric care stated, "they were called by the hospital, told the patient had expired an asked if they could come pick up the vent, they never said anything about the vent malfunctioning.".

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.Breas is waiting for the device to be returned.

Manufacturer Narrative

The device was returned, and we found no faults with this device.We looked at the alarm/events log and saw a lot of high/low pressure alarms, which could be caused by faulty circuits or incorrect settings selection.The device passed functional testing.There is a decent sized crack on the top screen.This is purely cosmetic damage.The conclusion is that the device operated as intended.Due to the time lapse between the adverse event (1 jan 2022) and this analysis, it cannot be concluded whether the crack was present during the event.Since it is cosmetic in nature, it would not have contributed to the event.Analysis of log files is not possible.The log files pertaining to the adverse event had been erased and it is therefore not possible to analyze any log files for this event.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 ; företagsvägen 1; mölnlycke, 43533 ; SW 43533
• MDR Report Key: 15593258
• MDR Text Key: 301623333
• Report Number: 9617566-2022-00010
• 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: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/11/2022

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
• Device Operator: Health Professional
• Device Model Number: BREAS VIVO 65
• Device Catalogue Number: 225000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 09/27/2022
• Supplement Dates FDA Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death