MAUDE Adverse Event Report: PRAXAIR DISTRIBUTION, INC.; CRYO TANK

Device Problems Gas Output Problem (1266); Manufacturing, Packaging or Shipping Problem (2975); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 10/14/2021

Event Type  malfunction  

Event Description

After changing out the cryo tank, the cryoablation machine stopped working.It was found that nitric oxide tank contains the wrong gas.The cyro tank should have non-medical grade air.It contained medical grade nitric oxide, which is used by anesthesia.Both tanks were appropriately labeled and are specific to the cryoablation console.This incorrect gas caused the console to malfunction.Once the correct gas from another tank was hooked up and tested, the machine worked fine.

• Type of Device: CRYO TANK
• Manufacturer (Section D): PRAXAIR DISTRIBUTION, INC.; 175 e park dr; tonawanda NY 14150
• MDR Report Key: 12778516
• MDR Text Key: 280528149
• Report Number: 12778516
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1