MAUDE Adverse Event Report: BREAS MEDICAL AB VIVO 45 LS; VENTILATOR

Model Number	230000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2024
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2024 at 8:13pm, breas received the following request from the healthcare provider: description: patient expired on (b)(6) 2024.Per wife, she found him disconnected.We are wanting verification that the vent was functioning properly.Per download alarms appear to have functioned as intended caregiver attendant: yes, when was the failure first detected? during the active treatment patient outcome: dead there is no allegation at this time that the device has malfunctioned or caused or contributed to the event.The customer sent the device to breas medical inc.For investigation on (b)(6) 2024 and the device arrived on (b)(6) 2024.
Additional Manufacturer Narrative
Investigation of the device started on nov 26, 2024.A flow test failure noted prior to calibration.This does not indicate an alarm failure.Device passed functional testing after flow recalibration.Per complainant, download alarms appear to have functioned as intended.The investigation could at this point not confirm that there had been malfunction.A complete analysis of the log file is still ongoing.
Additional Manufacturer Narrative
Investigation report: our reference: (b)(4).Your reference: n/a reporter: (b)(4).1 event summary and background.When was breas made aware of the event? october 25th, 2024.When did the event happen? (b)(6) 2024.When was the event discovered? during active treatment.Patient impact: death.Device model and serial# vivo 45 ls, sn (b)(6).Reporters description of the event: "patient expired on (b)(6) 2024.Per wife, she found him disconnected.We are wanting verification that the vent was functioning properly." other relevant background information: n/a.2 investigation: breas received the device on november 12th, 2024.The investigation started on november 26th, 2024 and completed on november 26th, 2024 the investigation included the following activities: analysis of log files, full functional testing.2.1 inspection: visual condition: device has normal signs of wear and tear.Some noticeable scuffs on the screen.Accessories: n/a.Affixed labels: three labels on the top case, placed by integris.System time and date: time: 15:05pm date: 11/26/2024.Device is 2 minutes behind current time.Firmware version: v5.1.5.Usage hours: 1466.6 hours.Interal battery: soh and soc soh: 96%, soc: 84%.Mode and setting as received: alarms as received: 2.2 analysis of log file.The alarm/events log shows that for the entirety of the treatment on (b)(6), the device was alarming the high priority alarms "low mve" and "low vte".Reviewing the settings that were set on the device during the time of the event, we see the "low pressure" alarm was set to 6cmh2o and the "peep" was also set to 6cmh2o.In this case, the device kept a base pressure of 6cmh2o which prevented the "disconnection" and "low pressure" alarms from sounding.The device functioned as expected with the settings that were programmed.2.3 calibration: as received: device failed the flow test at the highest test point.After recalibration: device passed all testing after flow calibration.2.4 functions and alarms: device passed all testing after recalibration.Including the buttons and alarm test.3 cause: is the root cause confirmed? the device functioned as designed, within the settings set at the time.Is the customer description confirmed or not? the alarms "low vte" and "low mve" would coexist with a disconnection event.This would confirm the description from the customer.Probable causes with rationale.The log files match a scenario where a disconnection event would occur.The device alarmed as designed within the specifications of the settings at the time.Causes that could be excluded with rationale n/a.4.Risk assessment: this event does not introduce a new risk.The device performed according to specification.5.Conclusion and recommended actions: the device performed according to specification within the settings set at the time.There is no fault found with the device.Report compiled by: (b)(4), service engineer.Date of report: 11/26/2024.
Event or Problem Description
"on oct 29, 2024 at 8:13pm, breas received the following request from the healthcare provider: description: patient expired on (b)(6) 2024.Per wife, she found him disconnected.We are wanting verification that the vent was functioning properly.Per download alarms appear to have functioned as intended.Caregiver attendant: yes.When was the failure first detected?: during the active treatment.Patient outcome: dead.There is no allegation at this time that the device has malfunctioned, or caused or contributed to the event.Breas received the device on november 12th, 2024 the investigation started on november 26th, 2024 and completed on november 26th, 2024 the investigation included the following activities: analysis of log files.Full functional testing.Investigation results: the alarm/events log shows that for the entirety of the treatment on (b)(6), the device was alarming the high priority alarms "low mve" and "low vte".Reviewing the settings that were set on the device during the time of the event, we see the "low pressure" alarm was set to 6cmh2o and the "peep" was also set to 6cmh2o.In this case, the device kept a base pressure of 6cmh2o which prevented the "disconnection" and "low pressure" alarms from sounding.The device functioned as expected with the settings that were programmed.There is no fault found with the device.

• Brand Name: VIVO 45 LS
• Common Device Name: VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotland SE-43 533; SW SE-43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotland 43533 ; SW 43533
• Manufacturer Contact: ivan liljegren ; foretagsvagen 1; molnlycke, vastra gotland 43533 ; SW 43533
• MDR Report Key: 20810183
• Report Number: 9617566-2024-00007
• Device Sequence Number: 9830964
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004(11)240308
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 230000
• Device Catalogue Number: 230016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 10/29/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: Death
• Patient Sex: Unknown