MAUDE Adverse Event Report: SUNMED VENTLAB; HUMDIIFIER

Model Number 6900

Device Problem Increase in Pressure (1491)

Patient Problem Cyanosis (1798)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up mdr will be filed once the investigation is complete.

Event Description

The customer alleges "patient was using bubble humidifier bottle at 8 lmp.He stated the pressure built up causing the humidifier to have bubbles.No air was exiting from the cannula side, it was coming out of the pressure release valve.It happened 3 times.Patient turned blue.".

• Brand Name: VENTLAB
• Type of Device: HUMDIIFIER
• Manufacturer (Section D): SUNMED; 2710 northridge dr. suite a; grand rapids MI 49544
• MDR Report Key: 12529067
• MDR Text Key: 281608046
• Report Number: 1314417-2021-00014
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 6900
• Device Lot Number: 321011
• Type of Device Usage: N
• Patient Sequence Number: 1