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

Model Number	230000
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Not applicable.
Event or Problem Description
Breas medical distributor reported "in attempting to give nebulizer treatment, patient's o2 saturation and heart rate decreased dramatically" as communicated by respiratory therapist.Distributor then spoke with icu physician who claimed she witnessed the incident and confirmed what the respiratory therapist claimed.The physician said her concern was the vivo 45 ls stopped giving a breath when nebulizer treatment was activated.No injury was claimed.Patient impact is absence of treatment.

• Brand Name: VIVO 45 LS
• Common Device Name: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer (Section G): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• Manufacturer Contact: gabriel vasiliu ; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 17181721
• Report Number: 9617566-2023-00004
• Device Sequence Number: 6630078
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004(11)230407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2023

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: 230000
• Device Catalogue Number: 223016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEBULIZER(NO ADDITIONAL INFO PROVIDED AT THE TIME
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown