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

Model Number	230000
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/26/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Breas received the device on september 24, 2025, and was inspected by the breas service department.The initial report did not allege that the breas device cause or contributed to the patient death.The investigation concluded that the breas device performed according to specification and there was no problem detected with the device.This report will be closed.
Event or Problem Description
On (b)(6) 2025, at 6:52 pm et, patient support rep (b)(6) contacted delivery technician (b)(6) about an issue with patient (b)(6)' (11-year-old patient) pulse oximeter.At 6:58 pm et, (b)(6) troubleshot the device with mom (b)(6) and a (b)(6) in-home nurse.Mom had already called 911 before contacting ams.Emergency services tested patients' vitals with their equipment and concluded the patient was stable and readings from (b)(6) equipment provided similar results and had left.The patient was reported stable at this time.(b)(6) prepared replacement equipment and departed for the patient's home at 7:20 pm et.He arrived at 9:20 pm et, where the nurse informed him that 911 had been called again during his travel time.(b)(6) exchanged both the pulse oximeter and patient cable, with the nurse signing for the exchange.During this process, mom called the nurse and informed them that the patient had passed away.At 9:51 pm et, (b)(6) contacted his supervisor (b)(6), who instructed him to document the incident.(b)(6) sent detailed information to (b)(6).He added a note to the patient's (b)(4) account, and the equipment was quarantined in the warehouse for further investigation.

• Brand Name: VIVO 45LS
• Common Device Name: VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlylcke, vastra gotland 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, vastra gotland 43533 ; SW 43533
• Manufacturer Contact: ramsey lancaster ; foretagsvagen 1; molnlycke, vastra gotland 43533 ; SW 43533
• MDR Report Key: 23294715
• Report Number: 9617566-2025-00021
• Device Sequence Number: 9917422
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: 010732182230000411240629
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 10/14/2025

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
• Device Model Number: 230000
• Device Catalogue Number: 230016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PULSE OXIMETER
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic