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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 Problems Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Patient Problem Sweating (2444)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative

A main electronics was ordered for this unit. Any additional information received from the customer will be included in a follow-up report.

 
Event Description

The customer reported that the main electronics of this device was damaged 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 Key8802793
MDR Text Key151443559
Report Number3004553423-2019-00063
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 COMPANY REPRESENTATIVE,DISTRI
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 Received05/27/2019
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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