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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMTMEDICAL AG BELLAVISTA; VENTILATOR, CONTINUOUS, FACILITY USE
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IMTMEDICAL AG BELLAVISTA; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number 1000
Device Problems Device Alarm System (1012); Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2020
Event Type  malfunction  
Event Description
We have a series of issues with 9 bellavista ventilators.These issues have been on-going since we purchased these ventilators and they all had a software upgrade which further made the issues worse.Here are the issues: the ventilator constantly alarming "occlusion" with no kink.On occasion high positive end expiratory pressure alarms for no reason.Power button to do normal shut down procedures doesn't work (screen locks).One ventilator inadvertently shut down during transport, needs a battery check.Pressure line on flow valve easily gets occluded.Patient's in non-invasive fraction of inspired oxygen (niv-fi02) can't go above 70%.Low pressure alarm ¿ can't decrease below 7.
 
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Brand Name
BELLAVISTA
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
IMTMEDICAL AG
26125 n riverwoods blvd
mettawa IL 60045
MDR Report Key10902799
MDR Text Key218212029
Report Number10902799
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/23/2020
Device Age1 YR
Event Location Hospital
Date Report to Manufacturer11/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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