MAUDE Adverse Event Report: ROTAREX INTELLIOX PLUS; GAS REGULATOR

Device Problem Gas Output Problem (1266)

Patient Problem Unspecified Respiratory Problem (4464)

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

Fda mw5144785.

Event Description

Patient was placed on 6l high flow on the portable tank.During transport, transport staff flagged down nursing staff as patient was becoming less responsive and disky in color enroute.Patient put on monitor showing desaturation.Switched to wall o2 and put on face mask.Patient's oxygenation quickly improved.It was noted that the portable o2 tank was showing full but no o2 is coming out, no matter how many liters it is set to.Device was taken out of service.Although malfunction has been proposed by user, the device has not been returned to manufacturer for inspection.

• Brand Name: INTELLIOX PLUS
• Type of Device: GAS REGULATOR
• Manufacturer (Section D): ROTAREX
• MDR Report Key: 17764160
• MDR Text Key: 323598798
• Report Number: 3003764448-2023-00002
• Device Sequence Number: 1
• Product Code: ECX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1