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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 Mechanical Problem (1384)
Patient Problems No Consequences Or Impact To Patient (2199); Sweating (2444)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative

Logs shows that several blower temperature high alarms are visible as well as blower failure alarm. A maximum temperature of 139. 6 degrees celsius was also recorded. Blower is damaged due to overheating caused by lack of maintenance. Customer has been informed that the blower and main electronics have to be replaced.

 
Event Description

The customer reported that alarm 316 - blower failure was active on this device during ventilation on a patient and resulted in poisoning. The patient had to be removed from this ventilator.

 
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Brand NameBELLAVISTA
Type of DeviceVENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
IMTMEDICAL AG
gewerbestrasse 8
buchs, 9470
SZ 9470
Manufacturer (Section G)
TECHNOCOM SYSTEMS SDN BHD
plo 1 jalan firma 1
kawasan perindustrian tebrau 1
johor bahru, 81100
MY 81100
Manufacturer Contact
stanley tan
22745 savi ranch pkwy
yorba linda, CA 92887
7149193324
MDR Report Key8802047
MDR Text Key151414718
Report Number3004553423-2019-00162
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK163127
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 12/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberBELLAVISTA 1000
Device Catalogue Number301.100.000
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/18/2019 Patient Sequence Number: 1
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