MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC WALK-O2-BOUT+ COMPRESSED OXYGEN; CYLINDER, COMPRESSED GAS, AND VALVE

Catalog Number UN1072

Patient Problem Insufficient Information (4580)

Event Date 10/17/2023

Event Type  malfunction  

Event Description

Emt was helping to transport patient from ed (emergency department) to radiology ct/medical imaging.Tank displayed 1,650 lbs.On gauge.Tank turned on and non-rebreather mask attached.Emt immediately noticed the bag did not inflate.Changed to another tank, which functioned appropriately.Tank was empty while displaying 1,650 lbs.Manufacturer response for e oxygen cylinder, compressed oxygen (per site reporter).Equipment failure reported to customer service at 866-935-3370 and connected to representative.Defective cylinder provided to airgas representative, while making exchanges on site.Full replacement cylinder provided in exchange and delivered to respiratory care/dme (durable medical equipment).

• Brand Name: WALK-O2-BOUT+ COMPRESSED OXYGEN
• Type of Device: CYLINDER, COMPRESSED GAS, AND VALVE
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; p/o. box 310; plumsteadville PA 18949
• MDR Report Key: 18064380
• MDR Text Key: 327265812
• Report Number: 18064380
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2023,10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UN1072
• Device Lot Number: S1013144XC04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Female
• Patient Weight: 89 KG
• Patient Race: White