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

Model Number	230000
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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
• 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: 16874473
• Report Number: 9617566-2023-00003
• Device Sequence Number: 12195115
• Product Code: NOU
• UDI-Device Identifier: 07321822300004
• UDI-Public: (01)07321822300004
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (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: SPO2 SENSOR
• Patient Sex: Unknown
• Patient Race: Black Or African American