MAUDE Adverse Event Report: BREAS MEDICAL AB VIVO 45 LS; CONTINUOUS, VENTILATOR, HOME USE

Model Number 230000

Device Problem Inaccurate Delivery (2339)

Patient Problems Dyspnea (1816); Loss of consciousness (2418)

Event Date 06/12/2023

Event Type  Injury  

Event Description

On (b)(6) 2023 breas medical gmbh received information that a vivo 45 ls had been involved in an incident in germany.Fault description per the reporter "patient beckoned that he does not get enough air from the device and fainted shortly after.Patient had to be ventilated by ambu bag and was connected to the spare device on which he had totally normal volume.The emergency doctor could not establish any secretion and accused the device as well.Date of incident: (b)(6) 2023 at 2 o`clock pm.A couple of weeks ago the nursery service called the emergency service because of the same device: mv low alarm.Due to not being a technical alarm the device was not replaced.It was working without any problem later.P.S.The device won´t stay in stand-by mode but will always shut down even if connected to mains." the patient involved was injured during the incident but could recover later.Investigation showed that the device was in good shape and was running for 1523 op.Hours and has firmware 3.1.9 loaded.The device was powered up and a pre-use test was carried out using an exhalation valve circuit with no failure.The power fail alarm was checked.It worked as intended and the device gave audible, with level for 85db ±5db that can't be changed or turned off, and visible alarms.A test run was performed under the patients' settings with no failure at first sight.The log files were downloaded and examined.Device has alarmed as designed and intended.The cause was found to be a defective piezo exhalation valve.

• Brand Name: VIVO 45 LS
• Type of Device: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotaland 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotaland 43533 ; SW 43533
• Manufacturer Contact: ivan liljegren ; foretagsvagen 1; molnlycke, vastra gotaland 43533 ; SW 43533
• MDR Report Key: 17258482
• MDR Text Key: 318545197
• Report Number: 9617566-2023-00005
• Device Sequence Number: 1
• Product Code: NOU
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K193586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 230000
• Device Catalogue Number: 230016
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention