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

Model Number BELLAVISTA 1000E

Device Problem Computer Software Problem (1112)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/18/2018

Event Type  Injury  

Manufacturer Narrative

Any additional information received from the customer will be included in a follow-up report.Received log files.It is visible that alarm 300 activated after an occlusion.This alarm is also active together with alarm 506 "technical failure 506 assertion id curves" when the machine returned for evaluation it was found out that there is a software bug.

Event Description

The customer reported alarm 300 "device in failsafe" to (b)(6).The nurse thought that the machine is "safe".The patient begun to desaturate and they had to change to manual ventilation and later to a different bellavista.Additionally, the customer reported the display was frozen.

Manufacturer Narrative

Technical support traced the fault to the use of the device.Ventilator does a self-check of the pressure sensor operation by verifying measured values are in a plausible range during operation.During suction the applied pressure may be outside the plausible range.When a non-plausible value is detected the device switches to a fail-safe/safe-state with alarm (no ventilation, the valves open to allow spontaneous breathing) the issue has only been reported by one institution and is associated with a specific treatment protocol/use with closed suction.The hospital has been made aware of the importance to choose correct and appropriate sized catheters for closed suction.Future software release for bellavista changed wording to "technical failure 300 - no ventilation - device in failsafe." cause is attributed software where the failsafe application activated.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 8921023
• MDR Text Key: 155259435
• Report Number: 3004553423-2019-00110
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K163127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BELLAVISTA 1000E
• Device Catalogue Number: 301.100.100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2018
• Initial Date Manufacturer Received: 09/18/2018
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 05/19/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention