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

Model Number BELLAVISTA 1000 NEO

Device Problems Mechanical Problem (1384); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/28/2020

Event Type  Injury  

Manufacturer Narrative

Results of investigation: an alarm 325 (epc fan does not rotate correctly) was triggered after start-up of the machine.The customer removed the back panel and it was found out that the fan was not connected.It was suspected that the main electronics was defective and needs replacement.The log shows that the epc fan speed was found as "0".

Event Description

The customer reported that the bellavista 1000 neo encountered technical failure 325 (embedded power pc fan does not rotate correctly).They attempted to restart the device but it did not resolved the issue and had caused the cpu (central processing unit) to overheat.The issue occurred during patient-use and the device was replaced with another ventilator.The customer confirmed that there was no patient harm associated with the reported event.

• 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 SYSTEM SDN. BHD.; plo 1 jalan firma 1; kawasan perindustrian tebrau 1; johor bahru, 81100 ; MY 81100
• Manufacturer Contact: peter sparacio ; 26125 n. riverwoods blvd.; mettawa, IL 60045 ; 8727570116
• MDR Report Key: 11114222
• MDR Text Key: 225063835
• Report Number: 3004553423-2020-00762
• Device Sequence Number: 1
• Product Code: CBK
• UDI-Device Identifier: 07640149381238
• UDI-Public: (01)07640149381238
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000 NEO
• Device Catalogue Number: 301.100.060
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Life Threatening; Other; Required Intervention