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

Model Number VIVO 65

Device Problem Defective Alarm (1014)

Patient Problem Death (1802)

Event Date 10/13/2020

Event Type  Death  

Manufacturer Narrative

The device was returned to the service site in the usa and an investigation was performed concluding that: the unit was functioning normally when received by breas.The vivo 65 alarmed in response to the adverse event.This device is functioning normally and worked as intended during the adverse event.The vivo 65's alarms were triggered in response to the event, even though the alarm that we would expect to be triggered in this instance (the apnea alarm) was disabled.This unit was retested on (b)(6) 2020 and is functioning normally.

Event Description

Unwitnessed death of a patient occurred while on the vivo 65.No alarms were activated.There was no formal complaint issued by the health care facility.

• Brand Name: VIVO 65
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, 43533 ; SW 43533
• MDR Report Key: 11365920
• MDR Text Key: 233078953
• Report Number: 3010817335-2020-00005
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07321822245169
• UDI-Public: 07321822245169
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 10/20/2020,11/03/2020

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
• Device Operator: Health Professional
• Device Model Number: VIVO 65
• Device Catalogue Number: 224000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2020
• Device Age: 1 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 10/20/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death