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

Model Number VIVO 50

Device Problems Defective Alarm (1014); Detachment of Device or Device Component (2907)

Patient Problem Loss of consciousness (2418)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: review of the log files on the device and standard functional testing of the device.In-depth review of the log files, which included analysis of the treatment data aimed at determining why the disconnection alarm, among others, was not triggered.Conclusions: the vivo 50 was operating normally and as intended during the disconnection event.Even though the vivo 50 detected changes in measurements indicative of a disconnection event, no alarms sounded because none of these changes in measurement were substantial enough to pass the alarm thresholds as they were set.

Event Description

A nurse walked into the resident's room to find the circuit disconnected and the resident non-responsive.No alarms were triggered.Nurse was unable to determine how long resident was disconnected.Per facility, the disconnect alarm triggered after moving the disconnected circuit from floor to trolley basket.

• Brand Name: VIVO 50
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): BREAS MEDICAL AB; foretagsvagen 1; molnlycke, sweden 43533 ; SW 43533
• MDR Report Key: 11365886
• MDR Text Key: 233079964
• Report Number: 3010817335-2020-00002
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 00732182215005
• UDI-Public: 0732182215005
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/16/2020,10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VIVO 50
• Device Catalogue Number: 215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/16/2020
• Distributor Facility Aware Date: 08/11/2020
• Device Age: 67 MO
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening