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U.S. Department of Health and Human Services

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

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BREAS MEDICAL AB VIVO 50 VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
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.

 
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Brand NameVIVO 50
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
BREAS MEDICAL AB
foretagsvagen 1
molnlycke, sweden 43533
SW 43533
MDR Report Key11365886
MDR Text Key233079964
Report Number3010817335-2020-00002
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
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 Received02/23/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberVIVO 50
Device Catalogue Number215000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2020
Distributor Facility Aware Date08/11/2020
Device Age67 mo
Event Location Nursing Home
Date Report TO Manufacturer09/16/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 02/23/2021 Patient Sequence Number: 1
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