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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 BELLAVISTA 1000
Device Problem Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2020
Event Type  Injury  
Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event Description
The customer reported that the bellavista 1000 is not sensing respiratory effort while the patient is in continuous positive airway pressure mode.The unit alarmed as apnea but in pressure support the unit senses the respiratory effort.The customer confirmed the patient was removed from the ventilator but no harm was reported associated with the event.
 
Manufacturer Narrative
Results of investigation: the suspect device was not returned for investigation.Vyaire medical determined root cause as due to unit software issue, an insufficient breath detection in cpap mode at high leak levels.Vyaire medical will upgrade the unit software to v6.0.1800.0 once available.
 
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Brand Name
BELLAVISTA
Type of Device
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
IMTMEDICAL AG
gewerbestrasse 8
buchs, 9470
SZ  9470
MDR Report Key10931457
MDR Text Key219129375
Report Number3004553423-2020-00711
Device Sequence Number1
Product Code CBK
Combination Product (y/n)N
PMA/PMN Number
K163127
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBELLAVISTA 1000
Device Catalogue Number301.100.030
Was Device Available for Evaluation? Yes
Date Manufacturer Received05/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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