MAUDE Adverse Event Report: AIRGAS USA INTELLI-OX; VIPR (VALVE INTEGRATED PRESSURE REGULATOR)

Model Number M70600216

Device Problems Incorrect Measurement (1383); High Readings (2459)

Patient Problem No Patient Involvement (2645)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Pressure gauge component is in transit to the gauge manufacturer for analysis.

Event Description

Airgas received a notice from a customer that the intelliox cylinder gauge was reading full but the cylinder was empty of product.

• Brand Name: INTELLI-OX
• Type of Device: VIPR (VALVE INTEGRATED PRESSURE REGULATOR)
• Manufacturer (Section D): AIRGAS USA; 12800 west little york rd.; houston TX 77041
• Manufacturer (Section G): AIRGAS USA; 12800 west little york rd.; houston TX 77041
• Manufacturer Contact: peter hart ; 259 radnor-chester road; radnor, PA 19087 ; 7245046586
• MDR Report Key: 9508092
• MDR Text Key: 219763896
• Report Number: 3003764448-2019-00001
• Device Sequence Number: 1
• Product Code: ECX
• Combination Product (y/n): N
• PMA/PMN Number: K161179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M70600216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1