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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 Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/11/2021
Event Type  malfunction  
Manufacturer Narrative
Vyaire medical file identification: (b)(4).Device evaluated by mfr: 81 other - 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 has technical failure 401 "inspiration valve or device leaky".There was no information of patient involvement reported from this event.
 
Manufacturer Narrative
Result of investigation: no failure detected.Most likely a leak on o2 cell port causes tf 401 which was later arrested before service visit.Machine tested by vyaire field service engineer.As per wo-00016083 "checked unit.Also found that the unit software was at 6.0.1100.0.Upgraded instrument.Tested unit.Unit working to specification.
 
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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 Key11624962
MDR Text Key244180561
Report Number3004553423-2021-00935
Device Sequence Number1
Product Code CBK
UDI-Device Identifier07640149388183
UDI-Public(01)07640149388183(11)20191227
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 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
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 Received05/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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