MAUDE Adverse Event Report: AIR LIQUIDE HEALTHCARE AMERICA CORPORATION INTELLI-OX; CYLINDER, COMPRESSED GAS, AND VALVE

Lot Number W0440226EE01

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Deliver (2338)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

Patient was transported on a ventilator to ct when airgas intelli-ox tank read oxygen failure.Patient subsequently began to desaturate into low 70% and required emergent tank switch out.The old airgas intelli-ox tank stil shlowed 75% full.

Event Description

Patient was transported on a ventilator to ct when airgas intelli-ox tank read oxygen failure.Patient subsequently began to desaturate into low 70% and required emergent tank switch out.The old airgas intelli-ox tank still showed 75% full.

• Brand Name: INTELLI-OX
• Type of Device: CYLINDER, COMPRESSED GAS, AND VALVE
• Manufacturer (Section D): AIR LIQUIDE HEALTHCARE AMERICA CORPORATION; 12800 west little york rd; houston TX 77041
• MDR Report Key: 10718079
• MDR Text Key: 212501663
• Report Number: 10718079
• Device Sequence Number: 1
• Product Code: ECX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: W0440226EE01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/14/2020
• Date Report to Manufacturer: 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 20805 DA