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

Model Number	VIVO 45 LS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/15/2024
Type of Reportable Event	Death
Event or Problem Description
On 07/16/2024, breas received the following information from distributor (b)(4)."pt passed on (b)(6) 2024 possibly in late afternoon.(b)(4) wasn't informed until 7/16 and received minimal details.The incident may have happened while the patient was in transport from a ppec facility that watches children.A cousin of the family works on a referral basis for a personal injury law firm and mentioned the situation the law firm.The family asked for the data, and when they were told that (b)(4) would need to down-load the data and then give them a copy, the attorneys took possession of the device.(b)(4) informed the lawyers that the device is not theirs to take.The lawyers asked for a purchase or rental price for the device so that they could retain custody of the device.(b)(4) supplied them with a number the lawyers then said that they will look for "someone who can download the data".(b)(4) informed them that was not a good idea.They informed them that an unqualified person could potentially delete all the data with a push of the wrong button.".It is alleged that the patient was connected to a vivo 45ls device, part number: 230216 and serial number: (b)(6), at the time of the adverse event, but this is not supported by the log files obtained from the device (see additional comments).There has been no indication that the device caused or contributed to the event at this time.
Additional Manufacturer Narrative
Breas medical inc.Does not have access to the physical device at this time; however, log files from the device were obtained which were analyzed by breas r&d.Log files indicate that the device, sn (b)(6), was not in use at the time the event was reported to have occurred on july 15, 2024.The log files show data from (b)(6) 2024.Treatment data ends on (b)(6) 2024.Data from the (b)(6) was related to device status only with there no treatment occurring on those days.The last data in the log files is on (b)(6) at the time the download was done by a breas employee.After analyzing this data, there is no indication of corruption to the file.Treatment sessions are recorded as well as alarms, all of which are consistent with device specifications.

• Brand Name: VIVO 45 LS
• Common Device Name: VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke,, vastra gotaland SE-43 533; SW SE-43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotaland 43533 ; SW 43533
• Manufacturer Contact: ramsey lancaster ; 16 esquire road; north billerica, MA 01862 ; 9194184439
• MDR Report Key: 19976204
• Report Number: 9617566-2024-00003
• Device Sequence Number: 8585749
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004(11)230818
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/13/2024

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
• Device Model Number: VIVO 45 LS
• Device Catalogue Number: 230000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• 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