MAUDE Adverse Event Report: BREAS MEDICAL AB BREAS VIVO 50; CONTINUOUS VENTILATOR

Model Number	VIVO 50
Medical Device Problem Codes	Device Operational Issue (2914); Maintenance Does Not Comply To Manufacturers Recommendations (2974)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	12/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Under (b)(4) law, patient information is considered confidential and will not be released by the hospital.
Event or Problem Description
The unit is 3,5 months old.During the night the vent stopped delivering pressure and shut down at approximately 1:56 am, while it was connected to main power supply.It didn't switch to internal battery.Based on our review of the device logs, the device appears to have sounded an alarm when the error occurred in accordance with the device's specifications, but breas medical (b)(4) is awaiting a return of the device to confirm that the alarms are operating properly.The patient's mother awoke at approximately 2:00 am to check on her child and saw the child was without oxygen and becoming blue and the vivo was not operating.She immediately started the vent and has said the unit was then operating fine and child started to breathe again.The device log indicates that the device was restarted at approximately 1:59 am.The child is presently in the hospital and in stable condition, but we don't have any other information about the status of the child.
Additional Manufacturer Narrative
Patient information: under european law, patient information is considered confidential and will not be released by the hospital.
Event or Problem Description
The unit is 3.5 months old.During the night the vent stopped delivering pressure and shut down at approximately 1:56 am, while it was connected to main power supply.It didn't switch to internal battery.Based on our review of the device logs, the device appears to have sounded an alarm when the error occurred in accordance with the device's specifications, but breas medical ab is awaiting a return of the device to confirm that the alarms are operating properly.The patient's mother awoke at approximately 2:00 am to check on her child and saw the child was without oxygen and becoming blue and the vivo was not operating.She immediately started the vent and has said the unit was then operating fine and child started to breathe again.The device log indicates that the device was restarted at approximately 1:59 am.The child is presently in the hospital and in stable condition, but we don't have any other information about the status of the child.
Additional Manufacturer Narrative
This submission is for correction of missing follow up report.This is follow-up #1.No other new complaint information has been added.
Event or Problem Description
The unit is 3,5 months old.During the night the vent stopped delivering pressure and shut down at approximately 1:56 am, while it was connected to main power supply.It didn't switch to internal battery.Based on our review of the device logs, the device appears to have sounded an alarm when the error occurred in accordance with the device's specifications, but breas medical ab is awaiting a return of the device to confirm that the alarms are operating properly.The patient's mother awoke at approximately 2:00 am to check on her child and saw the child was without oxygen and becoming blue and the vivo was not operating.She immediately started the vent and has said the unit was then operating fine and child started to breathe again.The device log indicates that the device was restarted at approximately 1:59 am.The child is presently in the hospital and in stable condition, but we don't have any other information about the status of the child.

• Brand Name: BREAS VIVO 50
• Common Device Name: CONTINUOUS VENTILATOR
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, SE-43 5 33; SW SE-435 33
• MDR Report Key: 6275488
• Report Number: 9617566-2017-00002
• Device Sequence Number: 393075
• Product Code: NOU
• UDI-Device Identifier: 07321822150005
• UDI-Public: 07321822150005
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Other,Inspection
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Patient Family Member or Friend
• Device Model Number: VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2017
• Initial Date Received by Manufacturer: 12/27/2016
• Supplement Date Received by Manufacturer: 12/27/2016; 12/27/2016
• Initial Report FDA Received Date: 01/25/2017
• Supplement Report FDA Received Date: 03/16/2021; 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization