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

Model Number	VIVO 45 LS
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Per mdr report (b)(4) as communicated by the fda to breas medical, inc on (b)(6)2 022: pt.Received vivo 45 after a software update and everything was working and then one day patient went to get on unit and it red error and would not allow patient to use ventilator.Mobile medical was not able to get unit to function so we gave him a replacement and sent unit back to manufacturer.The reporter mobile medical was contacted to determine the serial number of the device in question, as well as details of the event.It turned out that a complaint ticket was already opened for this particular event and is recorded in (b)(4).It was determined from the complaint investigation that the device stopped during device start up procedures, causing an alarm to sound, and showing internal function failure error 2 on the screen.It was confirmed that the patient involved did not suffer any injury or health consequences.Device log files were reviewed and it was confirmed that the device alarmed with internal function failure 2 several times.This error code signals a failure of the main pressure sensor during startup.The device has two pressure sensors, a main and a backup, which are calibrated during startup.The cause has been traced to improper tolerance found in sensors from some batches of this component, and has been addressed with corrective action together with the supplier.Based on information received, the failure is not considered likely to cause or contribute to a death or serious injury/deterioration of health if the event were to re-occur.The device has performed as designed and intended if a main pressure sensor functional failure occurs, by giving a high priority audible and visual alarm.There has been no patient harm reported as a result of the incident.Risk mitigation's currently in place are therefore considered effective to reduce the final risk level to afap (as far as possible).

• Brand Name: VIVO 45 LS
• Common Device Name: CONTINUOUS VENTILATOR, HOME USE
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 435 3 3; SW 435 33
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 435 3 3; SW 435 33
• Manufacturer Contact: bryan lucero ; 16 esquire rd; north billerica, MA 01862 ; 4342561045
• MDR Report Key: 16500707
• Report Number: 9617566-2023-00001
• Device Sequence Number: 6168746
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004(11)210603
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K193586
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: VIVO 45 LS
• Device Catalogue Number: 23000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown