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

Model Number 230000

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

Customer reported that the spo2 sensors were working on white patients but not african americans when used as an accessory to the breas vivo 45 ls ventilator.They are returning the sensors and cables for credit after they are checked out by the service team.A total of (b)(4) sensors were returned to breas medical inc.On 6 apr 2023.No device malfunction was reported for the vivo 45 ls ventilator.No patient impact was reported.

Manufacturer Narrative

A total of (b)(4) spo2 sensors (masimoset lncs® dci® spo2 adult reusable finger clip sensor, ref (b)(4), masimo corporation, irvine, ca) were returned to breas medical on apr 6, 2023.A malfunction of this accessory was reproduced on apr 12, 2023.The problem was reported to the accessory manufacturer.

• 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: 16874473
• MDR Text Key: 314726778
• Report Number: 9617566-2023-00003
• Device Sequence Number: 1
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004
• 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: Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 230000
• Device Catalogue Number: 230000
• Device Lot Number: MULTIPLE/UNSPECIFIED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SPO2 SENSOR
• Patient Race: Black Or African American