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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. BELLAVISTA 1000E VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL, INC. BELLAVISTA 1000E VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Device Problem Unexpected Shutdown (4019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/02/2020
Event Type  Injury  
Event Description
Rn noticed the ventilator lightly alarming in the patient's room.It appeared that the ventilator had shut down.The message read: bellavista detected a user interface issue.Please proceed as follows: decommission bellavista; turn off bellavista (press and release the power button, then wait for 2 seconds, then press and hold the power button until shutdown); contact local technical support.Factory defaults load the factory default settings.Staff entered the room to assess the patient and machine.I bagged the patient while rt disconnected the nonworking ventilator.Staff assisted with retrieving a working ventilator to connect the patient to, which was then immediately connected to the patient.Htn, recented tested positive for covid.Fda safety report id# (b)(4).
 
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Brand Name
BELLAVISTA 1000E VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL, INC.
MDR Report Key10520706
MDR Text Key206744551
Report NumberMW5096537
Device Sequence Number1
Product Code CBK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
Patient Weight81
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