MAUDE Adverse Event Report: VYAIRE SENSORMEDICS; AIR-OXYGEN BLENDER

Model Number 10273

Device Problems Loose or Intermittent Connection (1371); High Readings (2459); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pneumothorax (2012)

Event Date 10/13/2021

Event Type  Death  

Event Description

In efforts to oxygenate the infant, inhaled nitric oxide (ino) was administered via ino delivery device, with high flow oxygen blender.The blender read 100%; however, the analyzer read 21%.Abgs revealed po2 of <30.There were multiple efforts to troubleshoot the setup and identify the issue, the ino vendor was called while respiratory care and neonatology attempted to increase oxygenation.The infant sustained a pneumothorax.The infant's health was declining rapidly and passed with parents.Vendor assessment of equipment was requested.It was determined the ino device was working properly but the o2 blender was not.It was found that the nut retaining the knob of the o2 blender was loose and not providing the friction fit required for adjustment of o2 concentration.

• Brand Name: SENSORMEDICS
• Type of Device: AIR-OXYGEN BLENDER
• Manufacturer (Section D): VYAIRE; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 12871621
• MDR Text Key: 281231706
• Report Number: 12871621
• Device Sequence Number: 1
• Product Code: LSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10273
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2021
• Distributor Facility Aware Date: 10/21/2021
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 2 WK
• Patient Sex: Prefer Not To Disclose