MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; RESPIRATORY THERAPY DEVICE (HOMECARE USE)

Model Number	BREAS VIVO 50
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Owing to the effectiveness of the mitigations that are built-in to the design, the reported failure is not considered likely to lead to death or serious deterioration in health if the event were to reoccur.The device has performed as designed if a hardware failure is encountered in order to protect against a fault becoming a hazard.In conclusion, the device has acted as designed and intended when a situation occurs which compromises safe operation, by triggering audible and visual alarm.No further actions are planned at this time.Breas medical will continue to track and trend for similar issues.
Event or Problem Description
The log files could establish that treatment was started on (b)(6) 2021, at 09:25:27 on mains.Several "high-volume" alarms together with "disconnection" alarms occurred during the following 3 days and nights when suddenly function failure 39 occurred on (b)(6) 2021 at 23:04:23 and terminated active treatment with high priority audible and visual alarm.The subsequent alarms error 43 occurred as a result of the psu failure which caused error 39.The patient involved was not injured during the incident.

• Brand Name: BREAS VIVO 50
• Common Device Name: RESPIRATORY THERAPY DEVICE (HOMECARE USE)
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 12428312
• Report Number: 9617566-2021-00003
• Device Sequence Number: 17128533
• Product Code: NOU
• UDI-Device Identifier: 07321822150005
• UDI-Public: 7321822150005
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Repair,Inspection
• Type of Report: Initial
• Report Date (Section B): 09/06/2021

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: BREAS VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1