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

Model Number BELLAVISTA 1000

Device Problems Loss of Power (1475); Ventilation Problem in Device Environment (3027)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

Vyaire file identification:(b)(4).Any additional information received from the customer will be included in a follow-up report.The cause is suspected to be an o2 leak caused by the o2 component near the unit when the backup supply is taking over.

Event Description

Customer reported alarm 278 - "internal o2 sensor concentration high".It happened after a black out in the hospital.Patient involvement is unknown at this time.

Manufacturer Narrative

A vyaire representative went on-site to evaluate the device.Investigation analysis traced the reported issue to o2 enriched environment.Leaks in the o2 wall supply connectors, small room with machines running next to each other, and bad air circulation in the room were attributing the issue.Alarm limits and sensors will be checked regarding device and environmental issues.The issue will be internally investigated within vyaire.

Event Description

The customer reported that alarm 278 - "internal o2 sensor concentration high" was triggered during patient use.At this time, there was no information provided on patient harm or outcome.

• Brand Name: BELLAVISTA
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): IMTMEDICAL AG; gewerbestrasse 8; buchs, 9470 ; SZ 9470
• MDR Report Key: 8777672
• MDR Text Key: 150856513
• Report Number: 3004553423-2019-00239
• 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: 12/26/2018

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: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other