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

Device Problems Break (1069); Device Emits Odor (1425); High Test Results (2457); Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2018

Event Type  malfunction  

Event Description

On (b)(6) 2018, service tech discovered odor at carbon dioxide gas manifold coming from one cylinder.Co2 outlets were tested.Tests indicated elevated levels of hydrocarbons in the co2 line, not meeting nfpa99 standards.Co2 regulator and parts of manifold were found damaged and were replaced.Co2 was used during laparoscopic surgery for insufflation or during cardiovascular surgery for oxygen displacement / surgical fire prevention.

• Brand Name: GAS CYLINDER
• Type of Device: REGULATOR, PRESSURE, GAS CYLINDER
• Manufacturer (Section D): AIRGAS USA
• MDR Report Key: 8191622
• MDR Text Key: 131585842
• Report Number: MW5082516
• Device Sequence Number: 1
• Product Code: CAN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR