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	07/08/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Breas medical received the device for investigation on september 5, 2024.Investigation included an analysis of the log files, a visual inspection, and functional testing.Analysis of logs indicate that the vivo 45 ls accurately delivered treatment based on the modes that were set.The device also alarmed according to specifications when measured values fell out of alarm setting ranges.There, breas medical has determined that the device functioned as programmed and alarmed as designed.It is therefore reasonable to conclude that the device did not cause or contribute to the patient death.
Event or Problem Description
On august 26, 2024, breas medical was contacted by unified care services to inspect a vivo 45ls device, sn (b)(6), which was being used by a patient who died.The death occurred on (b)(6) 2024.No further details were provided about the even after multiple attempts to contact the initial reporter.There is no allegation that the device caused or contributed to the death of the patient.

• 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: ivan liljegren ; foretagsvagen 1; molnlycke, vastra gotaland 43533 ; SW 43533
• MDR Report Key: 20250350
• Report Number: 9617566-2024-00004
• Device Sequence Number: 12590916
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004(11)231213
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

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: 230000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Initial Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2023
• 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