MAUDE Adverse Event Report: MAXTEC, LLC MAXVENTURI; ANALYZER, GAS, OXYGEN, GASEOUS-PHASE

Lot Number EA38699009

Device Problem Failure to Deliver (2338)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

Patient was on high-flow cannula at 100%; cannula stopped delivering oxygen; patient was placed on bipap and there was no known harm to the patient.

• Brand Name: MAXVENTURI
• Type of Device: ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
• Manufacturer (Section D): MAXTEC, LLC; 2305 south 1070 west; salt lake city UT 84119
• MDR Report Key: 11684643
• MDR Text Key: 246012519
• Report Number: 11684643
• Device Sequence Number: 1
• Product Code: CCL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/09/2021,01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: EA38699009
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA