MAUDE Adverse Event Report: BREAS MEDICAL AB VIVO 65 US; CONTINUOUS, VENTILATOR, HOME USE

Model Number	VIVO 65 US
Health Effect - Clinical Code	Death (1802)
Date of Event	08/03/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Another vivo 65 (serial number (b)(4)) was on hand to be used as a backup ventilator.Based upon distributor's information, the backup device was not used.Upon receipt of the main and backup devices, an investigation of the units was conducted.This investigation consisted of a review of the log files on the device and functional testing of the device the conclusion of the investigation is: from review of log files: the main vivo 65 alarmed repeatedly at the time of the event, sounding apnea, disconnection, and obstruction alarms.The apnea alarm is sound when the vivo does not detect sufficient patient breaths, and as such it is expected in this situation.The backup device was not used on the day of the incident.The main and backup devices were subjected to functional testing: the main device passed functional testing and operated as intended.The backup device passed functional testing with the exception that it failed pediatric expiratory volume verification, but otherwise operated as intended.The last calibration on the backup device was performed 11/09/2018.The failing of pediatric expiratory volume verification during functional testing was likely due to the backup devices having gone uncalibrated for this long.After recalibration, the device passed functional testing.Both devices were operating normally (aside from the backup devices overdue for calibration) and worked as intended during the adverse event.The main devices sounded the expected alarms in response to the event the fault identified with the backup devices (i.E.Overdue for calibration) did not and could not have contributed to this event because the backup device was not in use.In addition, this fault (failure to properly measure pediatric expiratory volume) is a function that is only used with a dual limb circuit, while the patient was using an exhalation valve circuit.Both units have been retested and recalibrated on 8/19/2020 and are operating as intended.The conclusion is therefore that the breas devices have not caused or contributed to the adverse event.
Event or Problem Description
On (b)(6) 2020, patient was coded at home while being ventilated.911 was called, patient was bagged on the way to the hospital and then placed on a hospital ventilator.

• Brand Name: VIVO 65 US
• Common Device Name: CONTINUOUS, VENTILATOR, HOME USE
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, swe 43533 ; SW 43533
• MDR Report Key: 10451131
• Report Number: 3010817335-2020-00001
• Device Sequence Number: 3074336
• Product Code: NOU
• UDI-Device Identifier: 07321822245169
• UDI-Public: 07321822245169
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K160481
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/25/2020
• Report Date (Section F): 08/03/2020

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: Other
• Device Model Number: VIVO 65 US
• Device Catalogue Number: 224000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/03/2020
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 08/03/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 08/25/2020
• 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: Death