MAUDE Adverse Event Report: IMTMEDICAL AG BELLAVISTA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number BELLAVISTA 1000

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem Injury (2348)

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

Any additional information received from the customer will be included in a follow-up report.Latest log files are not provided and device has not been returned to the manufacturer.However, per the customer, the unit is working well after replacement of ssd and power supply.Several attempts to contact the customer for additional information such as exact date of the incident and injury leading to the surgery during the power supply failure were made.

Event Description

The customer reported that technical failure (tf) 210 was active while using the bellavista 1000.It was also reported the 24 volt is not available at the power supply outlet.The issue occurred during patient use, and the patient was removed from the ventilator and changed with another one.The customer reported patient injury, and surgery was performed.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, 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 Key: 8778305
• MDR Text Key: 150692797
• Report Number: 3004553423-2019-00033
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000
• Device Catalogue Number: 301.100.000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/19/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other