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U.S. Department of Health and Human Services

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

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BREAS MEDICAL AB VIVO 65 VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number VIVO 65
Device Problem Device Alarm System (1012)
Patient Problem Death (1802)
Event Date 10/15/2020
Event Type  Death  
Manufacturer Narrative

The device was returned to the service site in the usa and an investigation was performed concluding that: this device is functioning normally and worked as intended during the adverse event. The vivo 65's alarms are functioning normally. This unit was retested on october 27th, 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.

 
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Brand NameVIVO 65
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
BREAS MEDICAL AB
breas medical ab
foretagsvagen 1
molnlycke, 43533
SW 43533
MDR Report Key11365896
MDR Text Key233078958
Report Number3010817335-2020-00004
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 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
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 65
Device Catalogue Number224000
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Distributor Facility Aware Date10/18/2020
Device Age1 mo
Event Location Nursing Home
Date Report TO Manufacturer10/20/2020
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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