MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; RESPIRATORY THERAPY DEVICE (HOMECARE USE)

Model Number BREAS VIVO 50

Device Problem Pressure Problem (3012)

Patient Problem Insufficient Information (4580)

Event Date 11/09/2020

Event Type  malfunction  

Event Description

Incident description per the reporter: "patient had to be reanimated by emergency doctor, the buildup pressure was not correct".The patient involved was injured during the incident and was provided by the (b)(6) hospital.

Manufacturer Narrative

Review of the log files has been performed by breas medical ab shows that the device gave high priority alarm for low vti and mvi prior to the assumed time of the event at the same time the pressure rose to the maximum pressure setting.The device continued to deliver the same pressure in total 8 minutes before running out of battery and generating a power fail alarm.During this period there is no delivered volume registered.This could be a sign of blocked airpath in some way.Breas has requested more information about this event, but no further detail could be provided.The only information that was received was that it occurred during relocation from hospital to nursing home and therefor no other information is available.Review of the investigation performed by breas (b)(4) concludes that the functional test was carried out successfully.The device was started, and a pre-use test was performed followed by a test run on a test lung with the patient´s settings could be completed.Visual inspection of the psu board could establish a corroded component due to ingress of an unknown fluid.This is not considered to have any relation to the reported event.No fault with the device has been confirmed that could have caused the reported behavior.Owing to the effectiveness of the mitigations that are built-in to the design, the reported event is not considered likely to lead to death or serious deterioration in health if the event were to reoccur.The device has performed as designed and intended in a situation per the reported incident.

• Brand Name: BREAS VIVO 50
• Type of Device: RESPIRATORY THERAPY DEVICE (HOMECARE USE)
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 11515182
• MDR Text Key: 280459484
• Report Number: 9617566-2021-00001
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 00732182215005
• UDI-Public: 0732182215005
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/08/2021

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
• Device Operator: Health Professional
• Device Model Number: BREAS VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization