MAUDE Adverse Event Report: AIRGAS USA AIRGAS; REGULATOR, PRESSURE, GAS CYLINDER

Lot Number N3613136EE06

Device Problem No Flow (2991)

Patient Problem Low Oxygen Saturation (2477)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

During a critical response, a patient had to be transported for imaging.The rn placed the patient on nasal oxygen at 2lpm via intelli-ox tank that indicated it was "full." during transport, patient desaturated to mid 80s so o2 flow was increased to 6 lmp without improvement.Rn discovered that despite tank indicating it was full and dial being on, no oxygen was flowing.

Event Description

During a critical response, a patient had to be transported for imaging.The rn placed the patient on nasal oxygen at 2lpm via intelli-ox tank that indicated it was "full." during transport, patient desaturated to mid 80s so o2 flow was increased to 6 lmp without improvement.Rn discovered that despite tank indicating it was full and dial being on, no oxygen was flowing.

Event Description

During a critical response, a patient had to be transported for imaging.The rn placed the patient on nasal oxygen at 2lpm via intelli-ox tank that indicated it was "full." during transport, patient desaturated to mid 80s so o2 flow was increased to 6 lmp without improvement.Rn discovered that despite tank indicating it was full and dial being on, no oxygen was flowing.

• Brand Name: AIRGAS
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): AIRGAS USA; 12800 west little york road; p/o. box 310; houston TX 77041
• MDR Report Key: 17919127
• MDR Text Key: 325476596
• Report Number: 17919127
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: N3613136EE06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Sex: Female
• Patient Race: Black Or African American