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

Model Number 230000

Device Problem Accessory Incompatible (1004)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

Not applicable.

Event 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
• Type of Device: 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
• MDR Text Key: 318129134
• Report Number: 9617566-2023-00004
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004(11)230407
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K193586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 230000
• Device Catalogue Number: 223016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NEBULIZER(NO ADDITIONAL INFO PROVIDED AT THE TIME
• Patient Outcome(s): Other